Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Nebraska Lincoln
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Devin Rose
Associate Professor
University of Nebraska Lincoln
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
- •Do not fit the inclusion criteria
Outcomes
Primary Outcomes
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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.
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
Time Frame: 8 weeks
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.
Secondary Outcomes
- Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)(8 weeks)
- Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)(8 weeks)
- Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)(8 weeks)