Overview

Conditions obesity, overweight
Treatments fruits and vegetables, whole grain, control, whole grain + fruits and vegetables
Sponsor University of Nebraska Lincoln
Start date October 2015
End date July 2017
Trial size 100 participants
Trial identifier NCT02602496, UNebraskaLincolnFDST1

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; a combined 3 servings of whole grain per day and 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).

Recruiting in the following locations…

United States Nebraska
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose supportive care
Masking no masking
Arm
(Experimental)
3 servings of refined grains per day.
control
3 servings of refined grain
(Experimental)
5 servings of fruits and vegetable per day.
fruits and vegetables
5 servings of fruits or vegetables
(Experimental)
3 servings of whole grains per day.
whole grain
3 servings of whole grain
(Experimental)
3 servings of whole grains per day and 5 servings of fruits and vegetable per day.
whole grain + fruits and vegetables
3 servings of whole grain and 5 servings of fruits or vegetables

Primary Outcomes

Measure
Interleukin-6
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

Measure
Gut microbiota composition
time frame: 8 weeks

Eligibility Criteria

All 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 February 2017.
Information provided to ClinicalTrials.gov by University of Nebraska Lincoln.