Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

University of Nebraska

Status: Completed

Conditions: Overweight; Obesity

Treatments: Other: Control; Other: Whole Grain; Other: Fruits and Vegetables

Study type: Interventional

Funder types: Other

Identifiers

NCT02602496

UNebraskaLincolnFDST1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Control

Experimental group

Description:

3 servings of refined grains per day.

Treatment:

Other: Control

Fruits and Vegetables

Experimental group

Description:

5 servings of fruits and vegetable per day.

Treatment:

Other: Fruits and Vegetables

Whole Grain

Experimental group

Description:

3 servings of whole grains per day.

Treatment:

Other: Whole Grain