This trial is active, not recruiting.

Conditions obesity, overweight
Treatments fruits and vegetables, whole grain, control
Sponsor University of Nebraska Lincoln
Start date October 2015
End date August 2016
Trial size 100 participants
Trial identifier NCT02602496, UNebraskaLincolnFDST1


This study evaluates the impact of increased intake of fruits and vegetables or whole grains on markers of inflammation and gut microbial composition. One third of the participants will consume 3 servings of whole grain per day; one third will consume 5 servings of fruits and vegetables per day; and one third will consume 3 servings of refined grains.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
3 servings of refined grains per day.
3 servings of refined grain
5 servings of fruits and vegetable per day.
fruits and vegetables
5 servings of fruits or vegetables
3 servings of whole grains (wheat) per day.
whole grain
3 servings of whole grain

Primary Outcomes

time frame: 8 weeks
Tumor necrosis factor-α
time frame: 8 weeks
High sensitivity C-reactive protein
time frame: 8 weeks
Lipopolysaccharide binding protein
time frame: 8 weeks
6-Item gastrointestinal symptom measure
time frame: 1 Day

Secondary Outcomes

Gut microbiota composition
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
Principal investigator Devin J Rose, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Nebraska Lincoln.