Clinical trial NCT02602496: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Diet
Whole grain
Fruits
Vegetables
Gut health
Anti-inflammatory
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
measure: Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
measure: Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
measure: Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
measure: Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
measure: Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
Other outcomes:
measure: Change in Body Mass Index (Value at Week 8 Minus Value at Week 0)
timeFrame: 8 weeks
Locations:
city: Lincoln
country: United States
facility: Food Innovation Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Devin J Rose, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.