Food Effects on the Gut Microbiota

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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