Back to resultsAlmonds to Improve Gut Health and Decrease Inflammation
Primary Purpose
Metabolic Syndrome, Dysbiosis, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almond
Crackers
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria: Age 35-60 years 3 or more of the following: hypertension (systolic BP 130-179 mmHg or diastolic BP 85-119 mmHg); hyperglycemia (fasting glucose 100-599 mg/dL); central obesity [waist circumference greater than 40.1 inches (M) or 34.6 inches (F); hypertriglyceridemia (150-499 mg/dL); low HDL [lower than 40 mg/dL (M) or 50 mg/dL (F)] Willing to restrict consumption of nuts other than study nuts for 1 week prior to and throughout the study (13 weeks) Willing to stop probiotic supplements one week prior to and during the study (13 weeks) Willing to stop multivitamins and supplements containing vitamin E, magnesium, calcium, iron, zinc and copper one week prior to and during the study (13 weeks) Willing to complete intake diaries during the study Willing to maintain current eating patterns (no significant diet change during study) Exclusion Criteria: Weekly consumption of almonds, hazelnuts, peanuts and sunflower seeds combined greater than 2 servings (about 2 oz) in the past 3 months Nut, wheat, or gluten allergy/intolerance Regular use of vitamin E supplements Consume more than 2 alcoholic drinks daily Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past 3 months Pregnancy, breastfeeding, or planning to become pregnant before completing the study Vigorous exercise greater than 7 hours/week History of cardiovascular disease, liver disease or cancer Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedures (e.g. cholecystectomy), disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis) or chronic diarrhea Diagnosis of hemochromatosis Chronic use (daily intake in past 30 days) of anti-inflammatory medication (steroid or NSAID) Use of ezetimibe or orlistat Use of oral antibiotic medication within the past month Body Mass Index (BMI) <25.0 or >35.0 kg/m2 Regular use of multivitamin supplements in the past 3 months Physician prescribed use of probiotic, vitamin E, magnesium, calcium, iron, zinc or copper supplements
Sites / Locations
- Oregon State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Almonds
Crackers
Arm Description
Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
Outcomes
Primary Outcome Measures
Gut permeability and health: Serum endotoxin
Change from baseline at week 4: Marker of gut barrier function and health, serum endotoxin
Gut permeability and health: Short chain fatty acids
Change from baseline at week 4: Markers of gut barrier function and health fecal short chain fatty acids profiles
Gut permeability and health: Inflammatory biomarkers
Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase
Biomarkers of inflammation
Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6)
Oxidative stress status: malondialdehyde
Change from baseline at week 4: Plasma malondialdehyde
Oxidative stress status: isoprostanes
Change from baseline at week 4: Urinary isoprostanes
Cardiometabolic health
Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides
Vitamin E status
Change from baseline at week 4 and week 12: Plasma α-tocopherols
Vitamin E status: Urinary catabolite
Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (α-CEHC)
Secondary Outcome Measures
Blood pressure
Change from baseline at week 4 and week 12: Systolic, and diastolic blood pressure
Weight
Change from baseline at week 4 and week 12: Weight
BMI
Change from baseline at week 4 and week 12: BMI (weight and height will be combined to report BMI in kg/m^2)
Waist circumference
Change from baseline at week 4 and week 12: Waist circumference
Glycemic control: glucose
Change from baseline at week 12: Fasting blood glucose
Glycemic control: Insulin
Change from baseline at week 12: Insulin
Glycemic control: HOMA-IR
Change from baseline at week 12: HOMA-IR
Other almond-based bioactives (polyphenol levels)
Change from baseline at week 12: Urinary metabolites of flavonoids like (+)-catechin, (-)-epicatechin and naringenin
Mineral status
Change from baseline at week 12: Plasma magnesium, calcium, iron, zinc, and copper (microgram/mL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05790564
Brief Title
Almonds to Improve Gut Health and Decrease Inflammation
Official Title
Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
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
Almonds are a good source of beneficial compounds. This study will investigate if eating almonds everyday for 12 weeks can affect gut health and inflammation in persons with metabolic syndrome. Investigators will measure changes in metabolism, heart health, and the levels of vitamins and other compounds from almonds.
Detailed Description
Metabolic Syndrome (MetS) affects over a billion people world-wide. MetS progression and further health complications are driven by chronic inflammation. Major causes of inflammation in MetS are gut barrier breakdown and the absorption of harmful bacteria. What causes the gut barrier breakdown is not clear, but a poor diet, especially low micronutrient intakes like vitamin E, is implicated by propagating a vicious cycle that promotes oxidative stress, inflammation and further gut barrier damage. This study will assess the impact of daily consumption of 2 ounces of almonds for 12 weeks on gut health, markers of inflammation and cardiometabolic health, and micronutrient status in persons with MetS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Dysbiosis, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Almonds
Arm Type
Active Comparator
Arm Description
Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Arm Title
Crackers
Arm Type
Placebo Comparator
Arm Description
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
Intervention Type
Other
Intervention Name(s)
Almond
Intervention Description
Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
Intervention Type
Other
Intervention Name(s)
Crackers
Intervention Description
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
Primary Outcome Measure Information:
Title
Gut permeability and health: Serum endotoxin
Description
Change from baseline at week 4: Marker of gut barrier function and health, serum endotoxin
Time Frame
0 and 4 weeks
Title
Gut permeability and health: Short chain fatty acids
Description
Change from baseline at week 4: Markers of gut barrier function and health fecal short chain fatty acids profiles
Time Frame
0 and 4 weeks
Title
Gut permeability and health: Inflammatory biomarkers
Description
Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase
Time Frame
0 and 4 weeks
Title
Biomarkers of inflammation
Description
Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6)
Time Frame
0 and 4 weeks
Title
Oxidative stress status: malondialdehyde
Description
Change from baseline at week 4: Plasma malondialdehyde
Time Frame
0 and 4 weeks
Title
Oxidative stress status: isoprostanes
Description
Change from baseline at week 4: Urinary isoprostanes
Time Frame
0 and 4 weeks
Title
Cardiometabolic health
Description
Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides
Time Frame
0 and 12 weeks
Title
Vitamin E status
Description
Change from baseline at week 4 and week 12: Plasma α-tocopherols
Time Frame
0, 4 and 12 weeks
Title
Vitamin E status: Urinary catabolite
Description
Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (α-CEHC)
Time Frame
0, 4 and 12 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change from baseline at week 4 and week 12: Systolic, and diastolic blood pressure
Time Frame
0, 4 and 12 weeks
Title
Weight
Description
Change from baseline at week 4 and week 12: Weight
Time Frame
0, 4 and 12 weeks
Title
BMI
Description
Change from baseline at week 4 and week 12: BMI (weight and height will be combined to report BMI in kg/m^2)
Time Frame
0, 4 and 12 weeks
Title
Waist circumference
Description
Change from baseline at week 4 and week 12: Waist circumference
Time Frame
0, 4 and 12 weeks
Title
Glycemic control: glucose
Description
Change from baseline at week 12: Fasting blood glucose
Time Frame
0 and 12 weeks
Title
Glycemic control: Insulin
Description
Change from baseline at week 12: Insulin
Time Frame
0 and 12 weeks
Title
Glycemic control: HOMA-IR
Description
Change from baseline at week 12: HOMA-IR
Time Frame
0 and 12 weeks
Title
Other almond-based bioactives (polyphenol levels)
Description
Change from baseline at week 12: Urinary metabolites of flavonoids like (+)-catechin, (-)-epicatechin and naringenin
Time Frame
0 and 12 weeks
Title
Mineral status
Description
Change from baseline at week 12: Plasma magnesium, calcium, iron, zinc, and copper (microgram/mL)
Time Frame
0 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 35-60 years
3 or more of the following: hypertension (systolic BP 130-179 mmHg or diastolic BP 85-119 mmHg); hyperglycemia (fasting glucose 100-599 mg/dL); central obesity [waist circumference greater than 40.1 inches (M) or 34.6 inches (F); hypertriglyceridemia (150-499 mg/dL); low HDL [lower than 40 mg/dL (M) or 50 mg/dL (F)]
Willing to restrict consumption of nuts other than study nuts for 1 week prior to and throughout the study (13 weeks)
Willing to stop probiotic supplements one week prior to and during the study (13 weeks)
Willing to stop multivitamins and supplements containing vitamin E, magnesium, calcium, iron, zinc and copper one week prior to and during the study (13 weeks)
Willing to complete intake diaries during the study
Willing to maintain current eating patterns (no significant diet change during study)
Exclusion Criteria:
Weekly consumption of almonds, hazelnuts, peanuts and sunflower seeds combined greater than 2 servings (about 2 oz) in the past 3 months
Nut, wheat, or gluten allergy/intolerance
Regular use of vitamin E supplements
Consume more than 2 alcoholic drinks daily
Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past 3 months
Pregnancy, breastfeeding, or planning to become pregnant before completing the study
Vigorous exercise greater than 7 hours/week
History of cardiovascular disease, liver disease or cancer
Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedures (e.g. cholecystectomy), disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis) or chronic diarrhea
Diagnosis of hemochromatosis
Chronic use (daily intake in past 30 days) of anti-inflammatory medication (steroid or NSAID)
Use of ezetimibe or orlistat
Use of oral antibiotic medication within the past month
Body Mass Index (BMI) <25.0 or >35.0 kg/m2
Regular use of multivitamin supplements in the past 3 months
Physician prescribed use of probiotic, vitamin E, magnesium, calcium, iron, zinc or copper supplements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Beaver, PhD
Phone
541-737-5049
Email
laura.beaver@oregonstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Uesugi, RN, BSN, MS
Phone
541-737-3594
Email
lpi.research@oregonstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Beaver, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Beaver, PhD
Phone
541-737-5049
Email
laura.beaver@oregonstate.edu
First Name & Middle Initial & Last Name & Degree
Sandra Uesugi, RN, BSN, MS
Phone
541-737-3594
Email
lpi.research@oregonstate.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers without IRB approval.
Learn more about this trial
Almonds to Improve Gut Health and Decrease Inflammation
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