Skip to content

Food Effects on the Gut Microbiota

Effects of High-fiber Snack Foods on Human Gut Microbes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03078283
Enrollment
24
Registered
2017-03-13
Start date
2017-04-10
Completion date
2019-09-30
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbial Responses to Dietary Fiber

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.

Interventions

OTHERhigh-fiber food type

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

Sponsors

Mondelēz International, Inc.
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
31 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of gut microbial community structure and function8 weeksSequencing 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026