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FIBERME study

Predicting the intestinal microbiome response to dietary fibers, a pilot study - Fiberme

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58296
Enrollment
220
Registered
2025-06-25
Start date
2026-02-26
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Intestinal microbiome Gut flora

Interventions

A 6-week intervention period during which study participants take one of nine fiber supplements or a control supplement twice daily.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 years and older;Body mass index (BMI) =18 and =30 kg/m2Willing to keep a stable lifestyle, both diet and exercise, during the study period

Exclusion criteria

Exclusion criteria: Any known/diagnosed metabolic, gastrointestinal, inflammatory or chronic disease (such as anemia, diabetes, hepatitis, cardiovascular disease) that may significantly affect the study outcome or increase participant risk (judged by medical doctor);Having a history of medical or surgical events that may significantly affect the study outcome (judged by medical doctor), including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer;Use of medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives);Having a habitual dietary fiber intake of >25 grams (females) or >30 grams (males) a day, as calculated from the FiberScreen questionnaire during screening;Having less than 3 bowel movements per week, or more than 3 per day;Being gluten intolerant or having a corn allergy (self-reported);Use of antibiotic treatment less than 3 month before start of the study and during the study;Use of prebiotic, probiotic or postbiotic supplements (must be stopped at least 4 weeks before the first test day);Following a diet avoiding FODMAPSReporting to follow or having planned a slimming or medically prescribed diet.Average alcohol intake >14 (women) or >21 (men) of alcoholic units per week;Abuse of illicit drugs;Insufficient proficiency in Dutch to understand information brochure and questionnaires;Participation in any clinical trial including blood sampling and/or administration of substances up to 4 weeks before test day 1 of this study and during the study period;Being an employee of the department Food, Health & Consumer Research of Wageningen Food & Biobased Research (WFBR).

Design outcomes

Primary

MeasureTime frame
The change in relative abundance of CAZyme-encoding genes (GH [sub-]families) in fecal metagenomes.

Secondary

MeasureTime frame
Change in microbiome composition based on fecal metagenomes.

Countries

Netherlands

Contacts

Public ContactLM Janssen Duijghuijsen

Wageningen Universiteit

lonneke.janssenduijghuijsen@wur.nl+31648430236

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026