Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruits and Vegetables
Whole Grain
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity focused on measuring Diet, Whole grain, Fruits, Vegetables, Gut health, Anti-inflammatory
Eligibility Criteria
Inclusion Criteria:
- Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
- Free of known gastrointestinal disease
- No supplements use (excluding multivitamin)
- Participate in less than 1 h of exercise per week
- Have not taken antibiotics in the last six months
Exclusion Criteria:
- Men and women with fruits and vegetable intake exceeding 2 servings/day
- Men and women with whole grain intakes exceeding 1 serving/day
- Pregnant
- Do not fit the inclusion criteria
Sites / Locations
- Food Innovation Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control
Fruits and Vegetables
Whole Grain
Arm Description
3 servings of refined grains per day.
5 servings of fruits and vegetable per day.
3 servings of whole grains per day.
Outcomes
Primary Outcome Measures
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Secondary Outcome Measures
Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)
The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.
Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism.
Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography.
Full Information
NCT ID
NCT02602496
First Posted
November 4, 2015
Last Updated
May 22, 2019
Sponsor
University of Nebraska Lincoln
1. Study Identification
Unique Protocol Identification Number
NCT02602496
Brief Title
Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals
Official Title
Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska Lincoln
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).
Detailed Description
Literature data suggests that fruits and vegetables and whole grains containing dietary fiber and other nutrients are important for maintaining beneficial microbes in the gut. The presence of beneficial microbes in the gut may mediate the subclinical inflammation experienced in metabolic disease. In this project, overweight or obese participants with low intakes of fruits and vegetables or whole grains will increase their intake of these foods to recommended levels. Changes in markers of inflammation and gut microbiota composition will be determined to assess and compare the potential impact of these foods on metabolic disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Diet, Whole grain, Fruits, Vegetables, Gut health, Anti-inflammatory
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
3 servings of refined grains per day.
Arm Title
Fruits and Vegetables
Arm Type
Experimental
Arm Description
5 servings of fruits and vegetable per day.
Arm Title
Whole Grain
Arm Type
Experimental
Arm Description
3 servings of whole grains per day.
Intervention Type
Other
Intervention Name(s)
Fruits and Vegetables
Intervention Description
5 servings of fruits or vegetables
Intervention Type
Other
Intervention Name(s)
Whole Grain
Intervention Description
3 servings of whole grain
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
3 servings of refined grain
Primary Outcome Measure Information:
Title
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
Description
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Time Frame
8 weeks
Title
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
Description
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Time Frame
8 weeks
Title
Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)
Description
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Time Frame
8 weeks
Title
Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)
Description
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)
Description
The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.
Time Frame
8 weeks
Title
Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Description
Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism.
Time Frame
8 weeks
Title
Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
Description
Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change in Body Mass Index (Value at Week 8 Minus Value at Week 0)
Description
Body mass index will be measured on participants at the beginning (week 0) and end of the study (week 8). Changes in body mass index will be determined.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
Free of known gastrointestinal disease
No supplements use (excluding multivitamin)
Participate in less than 1 h of exercise per week
Have not taken antibiotics in the last six months
Exclusion Criteria:
Men and women with fruits and vegetable intake exceeding 2 servings/day
Men and women with whole grain intakes exceeding 1 serving/day
Pregnant
Do not fit the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devin J Rose, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Food Innovation Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68588
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30060746
Citation
Kopf JC, Suhr MJ, Clarke J, Eyun SI, Riethoven JM, Ramer-Tait AE, Rose DJ. Role of whole grains versus fruits and vegetables in reducing subclinical inflammation and promoting gastrointestinal health in individuals affected by overweight and obesity: a randomized controlled trial. Nutr J. 2018 Jul 30;17(1):72. doi: 10.1186/s12937-018-0381-7.
Results Reference
derived
Learn more about this trial
Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals
We'll reach out to this number within 24 hrs