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Combining HIIT and n-3 PUFA to Reduce Inflammation and Improve Metabolic Health (HIIT&PUFA)

Primary Purpose

Obesity, Inflammation, Human Microbiome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega-3 polyunsaturated fatty acid
High-Intensity Interval Training
Safflower oil
Flexibility training
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years old
  • Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2)
  • Elevated Triglycerides (>150 mg/dL)
  • Prediabetes (fasting blood glucose 100 to 125 mg/dl)

Exclusion Criteria:

  • Diagnosed with Diabetes or liver disease.
  • Taking BP or diabetes medications.
  • Received antibiotics medications in the last 6 months.
  • Pregnant/ lactating/ Irregular menstrual cycle/ menopausal.
  • Currently following a formal/ structured weight loss program.
  • Currently taking fish oil.
  • Do not have access to smart phone/ computer with internet access.
  • Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
  • Feeling uncomfortable riding bike for 30 minutes.
  • Claustrophobic or unable to stay under the hood for metabolic testing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Placebo & Flexibility Training (Control)

    Placebo & High-Intensity Interval Training

    n-3 PUFA & Flexibility Training (Control)

    n-3 PUFA & High-Intensity Interval Training

    Arm Description

    Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in low-intensity flexibility training (control group) for 30 minutes 3 times/week for 6 weeks, a time-matched session of stretching and mobility exercises. All exercise sessions will be performed on an exercise mat and conducted under investigator supervision. Participants will cease supplementation and flexibility training for a 2 week follow-up period.

    Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will cease supplementation and HIIT training for a 2 week follow-up period.

    Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in low-intensity flexibility training (control group) for 30 minutes 3 times/week for 6 weeks, a time-matched session of stretching and mobility exercises. All exercise sessions will be performed on an exercise mat and conducted under investigator supervision. Participants will cease supplementation and flexibility training for a 2 week follow-up period. During this time, participants will consume 8 oz per week or consuming fish twice weekly, including one serving of oily fish.

    Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will cease supplementation and HIIT training for a 2 week follow-up period. During this time, participants will consume 8 oz per week or consuming fish twice weekly, including one serving of oily fish.

    Outcomes

    Primary Outcome Measures

    Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks
    Interleukin (IL)-6 (pg/mL)
    Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks
    Interleukin (IL)-10 (pg/mL)
    Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Mean Change from Baseline in Tumor necrosis factor at 8 weeks
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Mean Change from Baseline in Total Cholesterol at 8 weeks
    Total cholesterol (mg/dL)
    Mean Change from Baseline in High-density lipoprotein (HDL)at 8 weeks
    High-density lipoprotein (HDL) (mg/dL)
    Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks
    Low-density lipoprotein (LDL) (mg/dL)
    Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Mean Change from Baseline in Triglycerides at 8 weeks
    Triglycerides (mg/dL).
    Mean Change from Baseline in Total/HDL cholesterol at 8 weeks
    Total/HDL cholesterol (mg/dL)
    Mean Change from Baseline in Fasting blood glucose at 8 weeks
    Fasting blood glucose (mg/dL)
    Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks
    Oral glucose tolerance test (OGTT) (mg/dL). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Mean Change from Baseline in Insulin at 8 weeks
    Insulin (μU/mL)
    Mean Change from Baseline in Total Body Fat Percentage at 8 weeks
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Mean Change from Baseline in Body weigh at 8 weeks
    Body weight (kilograms)
    Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 14 weeks
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Mean Change from Baseline in Monocyte chemoattractant protein-1 at 14 weeks
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Mean Change from Baseline in Interleukin (IL)-6 at 14 weeks
    Interleukin (IL)-6 (pg/mL)
    Mean Change from Baseline in Interleukin (IL)-10 at 14 weeks
    Interleukin (IL)-10 (pg/mL)
    Mean Change from Baseline in Tumor necrosis factor (TNF) at 14 weeks
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Mean Change from Baseline in Total Cholesterol at 14 weeks
    Total Cholesterol (mg/dL)
    Mean Change from Baseline in High-density lipoprotein (HDL) at 14 weeks
    High-density lipoprotein (HDL) (mg/dL)
    Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 14 weeks
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Mean Change from Baseline in Low-density lipoprotein (LDL) at 14 weeks
    Low-density lipoprotein (LDL) (mg/dL)
    Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 14 weeks
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Mean Change from Baseline in Triglycerides at 14 weeks
    Triglycerides (mg/dL).
    Mean Change from Baseline in total/HDL cholesterol at 14 weeks
    Total/HDL cholesterol (mg/dL)
    Mean Change from Baseline in Fasting blood glucose at 14 weeks
    Fasting blood glucose (mg/dL)
    Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 14 weeks
    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Mean Change from Baseline in Insulin at 14 weeks
    Insulin (μU/mL)
    Mean Change from Baseline in Body weight at 14 weeks
    Body weight (kilograms)
    Mean Change from Baseline in Total Body Fat Percentage at 14 weeks
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Mean Change from Baseline in Skeletal Muscle Mass Percentage at 14 weeks
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 16 weeks
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Mean Change from Baseline in Interleukin (IL)-6 at 16 weeks
    Interleukin (IL)-6 (pg/mL)
    Mean Change from Baseline in Interleukin (IL)-10 at 16 weeks
    Interleukin (IL)-10 (pg/mL)
    Mean Change from Baseline in Tumor necrosis factor (TNF) at 16 weeks
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Mean Change from Baseline in Monocyte chemoattractant protein-1 at 16 weeks
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Mean Change from Baseline in Total Cholesterol at 16 weeks
    Total Cholesterol (mg/dL)
    Mean Change from Baseline in High-density lipoprotein (HDL) at 16 weeks
    High-density lipoprotein (HDL) (mg/dL)
    Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 16 weeks
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Mean Change from Baseline in Low-density lipoprotein (LDL) at 16 weeks
    Low-density lipoprotein (LDL)(mg/dL)
    Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 16 weeks
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Mean Change from Baseline in Total/HDL cholesterol at 16 weeks
    Total/HDL cholesterol (mg/dL)
    Mean Change from Baseline in Triglycerides at 16 weeks
    Triglycerides (mg/dL)
    Mean Change from Baseline in Insulin at 16 weeks
    Insulin (μU/mL)
    Mean Change from Baseline in Fasting blood glucose at 16 weeks
    Fasting blood glucose (mg/dL)
    Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 16 weeks
    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Mean Change from Baseline in Skeletal Muscle Mass Percentage at 16 weeks
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Mean Change from Baseline in Body weight at 16 weeks
    Body weight (kilograms)
    Mean Change from Baseline in Total Body Fat Percentage at 16 weeks
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 14 weeks
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Mean Change from Post-Supplementation in Interleukin (IL)-6 at 14 weeks
    Interleukin (IL)-6 (pg/mL)
    Mean Change from Post-Supplementation in Interleukin (IL)-10 at 14 weeks
    Interleukin (IL)-10 (pg/mL)
    Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 14 weeks
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 14 weeks
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Mean Change from Post-Supplementation in Total Cholesterol at 14 weeks
    Total Cholesterol (mg/dL)
    Mean Change from Post-Supplementation in Total/HDL cholesterol at 14 weeks
    Total/HDL cholesterol (mg/dL)
    Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 14 weeks
    High-density lipoprotein (HDL) (mg/dL)
    Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 14 weeks
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 14 weeks
    Low-density lipoprotein (LDL) (mg/dL)
    Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 14 weeks
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Mean Change from Post-Supplementation in Triglycerides at 14 weeks
    Triglycerides (mg/dL)
    Mean Change from Post-Supplementation in Insulin at 14 weeks
    Insulin (μU/mL)
    Mean Change from Post-Supplementation in Oral glucose tolerance test (OGTT) at 14 weeks
    Oral glucose tolerance test (OGTT) Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Mean Change from Post-Supplementation in Fasting blood glucose at 14 weeks
    Fasting blood glucose (mg/dL)
    Mean Change from Post-Supplementation in Body weight at 14 weeks
    Body weight (kilograms)
    Mean Change from Post-Supplementation in Total Body Fat Percentage at 14 weeks
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Mean Change from Post-Supplementation in Skeletal Muscle Mass Percentage at 14 weeks
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 16 weeks
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 16 weeks
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Mean Change from Post-Intervention in Interleukin (IL)-6 at 16 weeks
    Interleukin (IL)-6 (pg/mL)
    Mean Change from Post-Intervention in Interleukin (IL)-10 at 16 weeks
    Interleukin (IL)-10 (pg/mL)
    Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 16 weeks
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Mean Change from Post-Intervention in Total Cholesterol at 16 weeks
    Total Cholesterol (mg/dL)
    Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 16 weeks
    High-density lipoprotein (HDL) (mg/dL)
    Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 16 weeks
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 16 weeks
    Low-density lipoprotein (LDL) (mg/dL)
    Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 16 weeks
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Mean Change from Post-Intervention in Total/HDL cholesterol at 16 weeks
    Total/HDL cholesterol (mg/dL)
    Mean Change from Post-Intervention in Triglycerides at 16 weeks
    Triglycerides (mg/dL)
    Mean Change from Post-Intervention in Insulin at 16 weeks
    Insulin (μU/mL)
    Mean Change from Post-Intervention in Fasting blood glucose at 16 weeks
    Fasting blood glucose (mg/dL)
    Mean Change from Post-Intervention in Oral glucose tolerance test (OGTT) at 16 weeks
    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Mean Change from Post-Intervention in Body weight at 16 weeks
    Body weight (kilograms)
    Mean Change from Post-Intervention in Total Body Fat Percentage at 16 weeks
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 16 weeks
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

    Secondary Outcome Measures

    Mean Change from Baseline in Bacterial Profile at 8 weeks
    Fecal Microbial DNA (16s Sequencing)
    Mean Change from Baseline in Serum Acetate Profile at 8 weeks
    Serum Acetate (SCFA: gas chromatography analysis)
    Mean Change from Baseline in Fecal acetate Profile at 8 weeks
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Propionate Profile at 8 weeks
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Butyrate Profile at 8 weeks
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks
    Serum lipopolysaccharides (LPS, ng/ml)
    Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Mean Change from Baseline in Bacterial Profile at 14 weeks
    Fecal Microbial DNA (16s Sequencing)
    Mean Change from Baseline in Serum Acetate Profile at 14 weeks
    Serum Acetate (SCFA: gas chromatography analysis)
    Mean Change from Baseline in Fecal acetate Profile at 14 weeks
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Propionate Profile at 14 weeks
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Butyrate Profile at 14 weeks
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Markers of Serum lipopolysaccharides at 14 weeks
    Serum lipopolysaccharides (LPS, ng/ml)
    Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 14 weeks
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Mean Change from Baseline in Serum Acetate Profile at 16 weeks
    Serum Acetate (SCFA: gas chromatography analysis)
    Mean Change from Baseline in Fecal acetate Profile at 16 weeks
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Bacterial Profile at 16 weeks
    Fecal Microbial DNA (16s Sequencing)
    Mean Change from Baseline in Propionate Profile at 16 weeks
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Butyrate Profile at 16 weeks
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Baseline in Markers of Serum lipopolysaccharides at 16 weeks
    Serum lipopolysaccharides (LPS, ng/ml)
    Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 16 weeks
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Mean Change from Post-Supplementation in Bacterial Profile at 14 weeks
    Fecal Microbial DNA (16s Sequencing)
    Mean Change from Post-Supplementation in Serum Acetate Profile at 14 weeks
    Serum Acetate (SCFA: gas chromatography analysis)
    Mean Change from Post-Supplementation in Fecal acetate Profile at 14 weeks
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Post-Supplementation in Propionate Profile at 14 weeks
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Post-Supplementation in Butyrate Profile at 14 weeks
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 14 weeks
    Serum lipopolysaccharides (LPS, ng/ml)
    Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 14 weeks
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Mean Change from Post-Intervention in Bacterial Profile at 16 weeks
    Fecal Microbial DNA (16s Sequencing)
    Mean Change from Post-Intervention in Serum Acetate Profile at 16 weeks
    Serum Acetate (SCFA: gas chromatography analysis)
    Mean Change from Post-Intervention in Fecal acetate Profile at 16 weeks
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Post-Intervention in Propionate Profile at 16 weeks
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Post-Intervention in Butyrate Profile at 16 weeks
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 16 weeks
    Serum lipopolysaccharides (LPS, ng/ml)
    Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 16 weeks
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)

    Full Information

    First Posted
    December 14, 2021
    Last Updated
    March 15, 2022
    Sponsor
    Texas Tech University
    Collaborators
    University of Houston, Texas Tech University Health Sciences Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05295719
    Brief Title
    Combining HIIT and n-3 PUFA to Reduce Inflammation and Improve Metabolic Health
    Acronym
    HIIT&PUFA
    Official Title
    Combining Fish Oil and Exercise to Improve Obesity-associated Inflammation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Texas Tech University
    Collaborators
    University of Houston, Texas Tech University Health Sciences Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.
    Detailed Description
    Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative to understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk. These studies will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia. The first aim of this study will focus on determining the combined effects of n-3 PUFA and HIIT on improving metabolic risks such as obesity-related markers of inflammation, dyslipidemia, and insulin resistance. The investigators will test the hypothesis that n-3 PUFA, in addition to HIIT, will have beneficial effects on energy utilization, as well as obesity-related markers of inflammation, dyslipidemia and insulin resistance. Aim 2.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition Aim 2.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity Aim 2.3: Investigate influence of n-3 PUFA and HIIT on energy utilization/ markers of insulin resistance The second aim is to determine the combined effects of n-3 polyunsaturated fatty acids (n-3 PUFA) and high-intensity interval training (HIIT) on improving gut dysbiosis. The investigators will test the hypothesis that n-3 PUFA supplementation will improve gut microbiota composition and related metabolites, which will result in reduced inflammation and ameliorate the metabolic response to a HIIT exercise intervention in an overweight population. Aim 1.1: Investigate the influence of n-3 PUFA and exercise on gut microbiota composition Aim 1.2: Investigate the influence of n-3 PUFA and exercise on microbiota produced metabolites Participants will be randomly allocated to 1 of 4 treatment groups (n = 120), each balanced for sex, BMI, lipid profile, and dietary intake. The goal is to conduct the study in smaller cohorts, such as 10-15 participants/group (n = 40-60). Participants will first be allocated to two groups: One group will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) and one group will take placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) for 8 weeks of initial supplementation. Following this, one group from the treatment and one from the placebo group (creating 4 groups: (1) placebo + exercise control; (2) n-3 PUFA + exercise control; (3) placebo + HIIT; (4) n-3 PUFA + HIIT) will also participate in a home-based 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program 3 days/week conducted at a local gym under virtual investigator supervision and utilizing cycle ergometers. If not asked to exercise, participants will be instructed to maintain their normal level of physical activity but will participate in a home-based, time-matched control consisting of flexibility training led virtually by investigators. All participants will wear a heart rate monitor (Polar H10) provided by TTU throughout the training (HIIT and control) to monitor exertion level. Capsules will be administered in a double-blind fashion and will be identical in appearance. Participants will visit the clinic to pick up capsules. To ensure compliance, subjects will be reminded via phone (text message or phone call based on participant preference) to take their capsules and counts will be conducted when they come in for study visits. As with any acute metabolic or physiological improvements, beneficial effects of exercise on bacterial taxa and resultant metabolite production are quickly reversed with detraining. Thus, it is of interest to determine if fish consumption can ameliorate the negative metabolic and gut effects of detraining. At the end of the 6-week intervention (week 14), participants in the respective groups will cease engaging in HIIT for a 2-week detraining period and those allocated to the fish oil group will receive recommendations for fish consumption according to guidelines (8 oz per week or consuming fish twice weekly, including one serving of oily fish). Dietary records for the last 2 weeks of the study will assess dietary fish intake compliance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Inflammation, Human Microbiome, Insulin Resistance, Dyslipidemias

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo & Flexibility Training (Control)
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in low-intensity flexibility training (control group) for 30 minutes 3 times/week for 6 weeks, a time-matched session of stretching and mobility exercises. All exercise sessions will be performed on an exercise mat and conducted under investigator supervision. Participants will cease supplementation and flexibility training for a 2 week follow-up period.
    Arm Title
    Placebo & High-Intensity Interval Training
    Arm Type
    Active Comparator
    Arm Description
    Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will cease supplementation and HIIT training for a 2 week follow-up period.
    Arm Title
    n-3 PUFA & Flexibility Training (Control)
    Arm Type
    Active Comparator
    Arm Description
    Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in low-intensity flexibility training (control group) for 30 minutes 3 times/week for 6 weeks, a time-matched session of stretching and mobility exercises. All exercise sessions will be performed on an exercise mat and conducted under investigator supervision. Participants will cease supplementation and flexibility training for a 2 week follow-up period. During this time, participants will consume 8 oz per week or consuming fish twice weekly, including one serving of oily fish.
    Arm Title
    n-3 PUFA & High-Intensity Interval Training
    Arm Type
    Experimental
    Arm Description
    Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 8 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will cease supplementation and HIIT training for a 2 week follow-up period. During this time, participants will consume 8 oz per week or consuming fish twice weekly, including one serving of oily fish.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega-3 polyunsaturated fatty acid
    Other Intervention Name(s)
    AlaskOmega
    Intervention Description
    4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA)
    Intervention Type
    Behavioral
    Intervention Name(s)
    High-Intensity Interval Training
    Other Intervention Name(s)
    HIIT
    Intervention Description
    A 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Safflower oil
    Other Intervention Name(s)
    Placebo
    Intervention Description
    4 grams safflower oil (AlaskOmega®) per day
    Intervention Type
    Behavioral
    Intervention Name(s)
    Flexibility training
    Intervention Description
    30 min of stretching 3 days/week for 6 weeks
    Primary Outcome Measure Information:
    Title
    Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks
    Description
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks
    Description
    Interleukin (IL)-6 (pg/mL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks
    Description
    Interleukin (IL)-10 (pg/mL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks
    Description
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Tumor necrosis factor at 8 weeks
    Description
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Total Cholesterol at 8 weeks
    Description
    Total cholesterol (mg/dL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in High-density lipoprotein (HDL)at 8 weeks
    Description
    High-density lipoprotein (HDL) (mg/dL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks
    Description
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks
    Description
    Low-density lipoprotein (LDL) (mg/dL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks
    Description
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Triglycerides at 8 weeks
    Description
    Triglycerides (mg/dL).
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Total/HDL cholesterol at 8 weeks
    Description
    Total/HDL cholesterol (mg/dL)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Fasting blood glucose at 8 weeks
    Description
    Fasting blood glucose (mg/dL)
    Time Frame
    Post-supplementation at week 8
    Title
    Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks
    Description
    Oral glucose tolerance test (OGTT) (mg/dL). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Time Frame
    Post-supplementation at week 8
    Title
    Mean Change from Baseline in Insulin at 8 weeks
    Description
    Insulin (μU/mL)
    Time Frame
    Post-supplementation at week 8
    Title
    Mean Change from Baseline in Total Body Fat Percentage at 8 weeks
    Description
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Body weigh at 8 weeks
    Description
    Body weight (kilograms)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks
    Description
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 14 weeks
    Description
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Monocyte chemoattractant protein-1 at 14 weeks
    Description
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Interleukin (IL)-6 at 14 weeks
    Description
    Interleukin (IL)-6 (pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Interleukin (IL)-10 at 14 weeks
    Description
    Interleukin (IL)-10 (pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Tumor necrosis factor (TNF) at 14 weeks
    Description
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Total Cholesterol at 14 weeks
    Description
    Total Cholesterol (mg/dL)
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in High-density lipoprotein (HDL) at 14 weeks
    Description
    High-density lipoprotein (HDL) (mg/dL)
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 14 weeks
    Description
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in Low-density lipoprotein (LDL) at 14 weeks
    Description
    Low-density lipoprotein (LDL) (mg/dL)
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 14 weeks
    Description
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in Triglycerides at 14 weeks
    Description
    Triglycerides (mg/dL).
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in total/HDL cholesterol at 14 weeks
    Description
    Total/HDL cholesterol (mg/dL)
    Time Frame
    Post-intervention at week 14
    Title
    Mean Change from Baseline in Fasting blood glucose at 14 weeks
    Description
    Fasting blood glucose (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 14 weeks
    Description
    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Insulin at 14 weeks
    Description
    Insulin (μU/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Body weight at 14 weeks
    Description
    Body weight (kilograms)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Total Body Fat Percentage at 14 weeks
    Description
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Skeletal Muscle Mass Percentage at 14 weeks
    Description
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 16 weeks
    Description
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Interleukin (IL)-6 at 16 weeks
    Description
    Interleukin (IL)-6 (pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Interleukin (IL)-10 at 16 weeks
    Description
    Interleukin (IL)-10 (pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Tumor necrosis factor (TNF) at 16 weeks
    Description
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Monocyte chemoattractant protein-1 at 16 weeks
    Description
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Total Cholesterol at 16 weeks
    Description
    Total Cholesterol (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in High-density lipoprotein (HDL) at 16 weeks
    Description
    High-density lipoprotein (HDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 16 weeks
    Description
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Low-density lipoprotein (LDL) at 16 weeks
    Description
    Low-density lipoprotein (LDL)(mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 16 weeks
    Description
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Total/HDL cholesterol at 16 weeks
    Description
    Total/HDL cholesterol (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Triglycerides at 16 weeks
    Description
    Triglycerides (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Insulin at 16 weeks
    Description
    Insulin (μU/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Fasting blood glucose at 16 weeks
    Description
    Fasting blood glucose (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 16 weeks
    Description
    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Skeletal Muscle Mass Percentage at 16 weeks
    Description
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Body weight at 16 weeks
    Description
    Body weight (kilograms)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Total Body Fat Percentage at 16 weeks
    Description
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 14 weeks
    Description
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Interleukin (IL)-6 at 14 weeks
    Description
    Interleukin (IL)-6 (pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Interleukin (IL)-10 at 14 weeks
    Description
    Interleukin (IL)-10 (pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 14 weeks
    Description
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 14 weeks
    Description
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Total Cholesterol at 14 weeks
    Description
    Total Cholesterol (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Total/HDL cholesterol at 14 weeks
    Description
    Total/HDL cholesterol (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 14 weeks
    Description
    High-density lipoprotein (HDL) (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 14 weeks
    Description
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 14 weeks
    Description
    Low-density lipoprotein (LDL) (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 14 weeks
    Description
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Triglycerides at 14 weeks
    Description
    Triglycerides (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Insulin at 14 weeks
    Description
    Insulin (μU/mL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Oral glucose tolerance test (OGTT) at 14 weeks
    Description
    Oral glucose tolerance test (OGTT) Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Fasting blood glucose at 14 weeks
    Description
    Fasting blood glucose (mg/dL)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Body weight at 14 weeks
    Description
    Body weight (kilograms)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Total Body Fat Percentage at 14 weeks
    Description
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Skeletal Muscle Mass Percentage at 14 weeks
    Description
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 16 weeks
    Description
    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 16 weeks
    Description
    Tumor necrosis factor (TNF)-alpha (pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Interleukin (IL)-6 at 16 weeks
    Description
    Interleukin (IL)-6 (pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Interleukin (IL)-10 at 16 weeks
    Description
    Interleukin (IL)-10 (pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 16 weeks
    Description
    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Total Cholesterol at 16 weeks
    Description
    Total Cholesterol (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 16 weeks
    Description
    High-density lipoprotein (HDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 16 weeks
    Description
    Non-high-density lipoprotein (Non-HDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 16 weeks
    Description
    Low-density lipoprotein (LDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 16 weeks
    Description
    Very-low-density lipoprotein (VLDL) (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Total/HDL cholesterol at 16 weeks
    Description
    Total/HDL cholesterol (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Triglycerides at 16 weeks
    Description
    Triglycerides (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Insulin at 16 weeks
    Description
    Insulin (μU/mL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Fasting blood glucose at 16 weeks
    Description
    Fasting blood glucose (mg/dL)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Oral glucose tolerance test (OGTT) at 16 weeks
    Description
    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Body weight at 16 weeks
    Description
    Body weight (kilograms)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Total Body Fat Percentage at 16 weeks
    Description
    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 16 weeks
    Description
    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
    Time Frame
    Post-Feeding at week 16
    Secondary Outcome Measure Information:
    Title
    Mean Change from Baseline in Bacterial Profile at 8 weeks
    Description
    Fecal Microbial DNA (16s Sequencing)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Serum Acetate Profile at 8 weeks
    Description
    Serum Acetate (SCFA: gas chromatography analysis)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Fecal acetate Profile at 8 weeks
    Description
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Propionate Profile at 8 weeks
    Description
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Butyrate Profile at 8 weeks
    Description
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks
    Description
    Serum lipopolysaccharides (LPS, ng/ml)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks
    Description
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Time Frame
    Post-Supplementation at week 8
    Title
    Mean Change from Baseline in Bacterial Profile at 14 weeks
    Description
    Fecal Microbial DNA (16s Sequencing)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Serum Acetate Profile at 14 weeks
    Description
    Serum Acetate (SCFA: gas chromatography analysis)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Fecal acetate Profile at 14 weeks
    Description
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Propionate Profile at 14 weeks
    Description
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Butyrate Profile at 14 weeks
    Description
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Markers of Serum lipopolysaccharides at 14 weeks
    Description
    Serum lipopolysaccharides (LPS, ng/ml)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 14 weeks
    Description
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Baseline in Serum Acetate Profile at 16 weeks
    Description
    Serum Acetate (SCFA: gas chromatography analysis)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Fecal acetate Profile at 16 weeks
    Description
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Bacterial Profile at 16 weeks
    Description
    Fecal Microbial DNA (16s Sequencing)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Propionate Profile at 16 weeks
    Description
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Butyrate Profile at 16 weeks
    Description
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Markers of Serum lipopolysaccharides at 16 weeks
    Description
    Serum lipopolysaccharides (LPS, ng/ml)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 16 weeks
    Description
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Supplementation in Bacterial Profile at 14 weeks
    Description
    Fecal Microbial DNA (16s Sequencing)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Serum Acetate Profile at 14 weeks
    Description
    Serum Acetate (SCFA: gas chromatography analysis)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Fecal acetate Profile at 14 weeks
    Description
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Propionate Profile at 14 weeks
    Description
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Butyrate Profile at 14 weeks
    Description
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 14 weeks
    Description
    Serum lipopolysaccharides (LPS, ng/ml)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 14 weeks
    Description
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Time Frame
    Post-Intervention at week 14
    Title
    Mean Change from Post-Intervention in Bacterial Profile at 16 weeks
    Description
    Fecal Microbial DNA (16s Sequencing)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Serum Acetate Profile at 16 weeks
    Description
    Serum Acetate (SCFA: gas chromatography analysis)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Fecal acetate Profile at 16 weeks
    Description
    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Propionate Profile at 16 weeks
    Description
    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Butyrate Profile at 16 weeks
    Description
    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 16 weeks
    Description
    Serum lipopolysaccharides (LPS, ng/ml)
    Time Frame
    Post-Feeding at week 16
    Title
    Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 16 weeks
    Description
    Serum lipopolysaccharides-binding protein (LBP, pg/ml)
    Time Frame
    Post-Feeding at week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-65 years old Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2) Elevated Triglycerides (>150 mg/dL) Prediabetes (fasting blood glucose 100 to 125 mg/dl) Exclusion Criteria: Diagnosed with Diabetes or liver disease. Taking BP or diabetes medications. Received antibiotics medications in the last 6 months. Pregnant/ lactating/ Irregular menstrual cycle/ menopausal. Currently following a formal/ structured weight loss program. Currently taking fish oil. Do not have access to smart phone/ computer with internet access. Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire. Feeling uncomfortable riding bike for 30 minutes. Claustrophobic or unable to stay under the hood for metabolic testing.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kembra D Albracht-Schulte, Ph.D.
    Phone
    +1 (806)-834-5786
    Email
    kembra.albracht@ttu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rama RC Chemitiganti, MBBS
    Email
    rama.chemitiganti@ttuhsc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kembra D Albracht-Schulte, Ph.D
    Organizational Affiliation
    Texas Tech University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Combining HIIT and n-3 PUFA to Reduce Inflammation and Improve Metabolic Health

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