Food Effects on the Gut Microbiota

NCT03078283 | Completed

• 1 other identifier: MDLZ2017JIG1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Microbial Responses to Dietary Fiber

Outcome Measures

Primary Outcomes (1)

• Assessment of gut microbial community structure and function

  Sequencing bacterial 16S rRNA amplicons plus shotgun sequencing of fecal community DNA to identify effects of fiber-enriched foods on bacterial community and gene representation; mass spectrometry of products of gut microbial community metabolism.

  8 weeks

Study Arms (1)

Participants

EXPERIMENTAL

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

Other: high-fiber food type

Interventions

high-fiber food type OTHER

In 3 successive experiments, usual diet will be supplemented with snack foods containing fiber of plant, fruit or grain origin.

Participants

Eligibility Criteria

• Age: 31 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Mondelēz International, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.

  PMID: 24009397 BACKGROUND

Study Officials

• Jeffrey I Gordon, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Robert J. Glaser Distinguished University Professor

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: April 10, 2017
• Primary Completion: December 31, 2018
• Study Completion: September 30, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)