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OpenTrials
Completed

NCT Number: NCT03078283

Food Effects on the Gut Microbiota

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.

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Key information

Age range

31 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of gut microbial community structure and function

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Mondelēz International, Inc.

Registry information

Official study title

Effects of High-fiber Snack Foods on Human Gut Microbes

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 13, 2017
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.