Food Effects on the Gut Microbiota

The Washington University

Status: Completed

Conditions: Gut Microbial Responses to Dietary Fiber

Treatments: Other: high-fiber food type

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03078283

MDLZ2017JIG1

Details and patient eligibility

About

This is a small-scale study of the effects on microbes in the human gut of adding high-fiber snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc. Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the study. They will complete 3 successive experiments in which their regular diet is supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one week consuming one snack food per day (approximately 7 g fiber, collection of all fecal samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber, collection of all fecal samples), (iv) four weeks consuming three snack foods per day (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only regular diet (weekly collection of fecal sample). For each experiment, participants will also provide a fasting blood sample during the free diet phase at the end of the week just before initiation of snack consumption, and a fasting blood sample at the end of the last week of snack consumption. Participants will also collect one first morning urine sample weekly throughout the study. During week 2, participants will also collect first morning urine samples for 3 consecutive days. Similarly, they will collect first morning urine samples for the last 3 consecutive days of the last week of snack consumption. The study will test the effects of the different fiber-rich snacks on the composition and metabolic properties of the gut microbial community in lean and obese subjects.

Enrollment: 24 patients

Sex: Female

Ages: 31 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

* member of female dizygotic twin pair discordant or concordant for obesity

Exclusion criteria

• pregnant or trying to get pregnant
• inflammatory bowel disease
• gastrointestinal cancer
• hepatitis
• HIV
• renal failure
• food allergies

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Participants

Experimental group

Description:

Consumption of a given type of high-fiber snack food, with each individual functioning as her own control

Treatment:

Other: high-fiber food type