Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

3 servings of refined grains per day.

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

3 servings of refined grain

Fruits and Vegetables

5 servings of fruits and vegetable per day.

Group Type EXPERIMENTAL

Fruits and Vegetables

Intervention Type OTHER

5 servings of fruits or vegetables

Whole Grain

3 servings of whole grains per day.

Group Type EXPERIMENTAL

Whole Grain

Intervention Type OTHER

3 servings of whole grain

Interventions

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Fruits and Vegetables

5 servings of fruits or vegetables

Intervention Type OTHER

Whole Grain

3 servings of whole grain

Intervention Type OTHER

Control

3 servings of refined grain

Intervention Type OTHER

Eligibility Criteria

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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