N/A
N=52
Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals
Obesity · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT02602496 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0) — 0.35; -1.08; 0.51 pg/mL — p=0.9942
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fruits and Vegetables (Other); Whole Grain (Other); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Nebraska Lincoln
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0) |
0.35; -1.08; 0.51 | 0.9942 |
| PRIMARY Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0) |
-0.36; -1.11; -5.40 | 0.5096 |
| PRIMARY Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0) |
0.01; -0.06; 0.00 | 0.9708 |
| PRIMARY Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0) |
0.14; -0.21; -0.21 | 0.0868 |
| SECONDARY Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0) |
0.05; 0.12; -0.15 | 0.9255 |
| SECONDARY Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) |
-45.82; 10.72; 2.88 | 0.2252 |
| SECONDARY Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0) |
-0.20; -2.41; 0.16 | 0.8323 |
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).
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
Data sourced from ClinicalTrials.gov (NCT02602496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.