The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals (FIBRE-MATCH)

June 1, 2026 updated by: Örebro University, Sweden

Characterization of Fiber-degrading Microbiota in Individuals Without Gastrointestinal Diseases

The aim of this crossover intervention study is to evaluate the volatile organic compounds (VOCs) present in participants at baseline and how these levels change after consuming either a low- or high-dietary fiber diet for three days. This study will involve adults, 18-65 years old, without any gastrointestinal diseases.

The primary objectives are to characterize baseline VOC profiles, assess changes in these profiles after a short-term dietary fiber intervention, determine if specific VOC patterns correlate with dietary fiber intake, and identify the time points at which VOC levels peak. This information will help establish the optimal timing for breath sampling and potentially provide insight into how VOC patterns relate to dietary fiber consumption and degradation.

The expected outcome is that a high-dietary fiber diet will produce a VOC profile enriched in metabolites associated with fiber fermentation compared to a low-dietary fiber diet, and that these VOCs will be consistent with those identified in vitro during fecal fermentation. Each participant will serve as an internal control, enabling within-subject comparisons of VOC levels at baseline and following the dietary fiber intervention.

Participants will receive a whole-food product that is rich in dietary fiber and will consume either a low-fiber diet (10 g/day) or a high-fiber diet (40 g/day) for three days. On the first day of each intervention, participants will also ingest a pH capsule to monitor gastrointestinal pH continuously throughout the three days. After a three-week washout period, participants will cross over to the other intervention arm and undergo another round of gastrointestinal pH monitoring.

In addition to the dietary intervention, participants will complete food and health questionnaires to assess habitual fiber intake and dietary habits. Fecal samples will be collected for in vitro fermentation to functionally profile the gut microbiota by assessing fecal VOCs, short-chain fatty acids (SCFA), and the microbial enzymatic activity and its pH-dependent modulation.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Signed informed consent obtained prior to any study-related procedures.
  2. Willingness to refrain from regular consumption of prebiotic or probiotic products, as well as medications known to affect gastrointestinal function, for at least four weeks prior to the study visits.

Exclusion Criteria:

  1. History of complicated gastrointestinal surgery.
  2. Presence of a gastrointestinal diagnosis or any condition that, in the opinion of the principal investigator, may influence the study outcomes.
  3. Current diagnosis of a psychiatric disorder.
  4. Systemic use of antibiotics or steroid medications within the past 3 months.
  5. Frequent use of NSAIDs (non-steroidal anti-inflammatory drugs) within the 2 months preceding the study visit.
  6. Regular consumption of prebiotic or probiotic products within the past 4 weeks.
  7. Alcohol or substance abuse.
  8. Current smoking or use of nicotine pouches.
  9. Frequent use of laxatives, antidiarrheal agents, or anticholinergic medications within the 12 weeks preceding the study visit.
  10. Pregnancy or breastfeeding.
  11. Respiratory disease or infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Fiber Diet, Then High Fiber Diet
Participants will receive a whole food dietary fiber product to consume 10g of dietary fiber per day over a total of 3 days, equal to a high fiber diet. After a washout period of 3 weeks, they then receive the same whole food dietary fiber product, to consume 40g of dietary fiber per day in a total of 3 days, equal to a high fiber diet.

Dietary Intervention: Low Fiber Diet

Whole food dietary fiber product, 10g of dietary fiber consumed per day for 3 days

Dietary Intervention: High Fiber Diet

Whole food dietary fiber product, 40g of dietary fiber consumed per day for 3 days

Experimental: High Fiber Diet, Then Low Fiber Diet
Participants will receive a whole food dietary fiber product to consume 40g of dietary fiber per day over a total of 3 days, equal to a high fiber diet. After a washout period of 3 weeks, they then receive the same whole food dietary fiber product, to consume 10g of dietary fiber per day in a total of 3 days, equal to a high fiber diet.

Dietary Intervention: High Fiber Diet

Whole food dietary fiber product, 40g of dietary fiber consumed per day for 3 days

Dietary Intervention: Low Fiber Diet

Whole food dietary fiber product, 10g of dietary fiber consumed per day for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of a 3-day low fiber diet compared to a 3-day high fiber diet on the Volatile Organic Compound profiles in exhaled breath
Time Frame: 5 weeks
Volatile Organic Compound profiles in produced by the 3-day low fiber diet intervention compared to the profiles produced by the 3-day high fiber diet, with a 3-week washout inbetween
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of a low fiber diet on Volatile Organic Compound profiles after 4 hours
Time Frame: 4 hours
Volatile organic compound profiles 4 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
4 hours
Effect of a low fiber diet on Volatile Organic Compound profiles after 6 hours
Time Frame: 6 hours
Volatile organic compound profiles 6 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
6 hours
Effect of a low fiber diet on Volatile Organic Compound profiles after 8 hours
Time Frame: 8 hours
Volatile organic compound profiles 8 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
8 hours
Effect of a high fiber diet on Volatile Organic Compound profiles after 4 hours
Time Frame: 4 hours
Volatile organic compound profiles 4 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
4 hours
Effect of a high fiber diet on Volatile Organic Compound profiles after 6 hours
Time Frame: 6 hours
Volatile organic compound profiles 6 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
6 hours
Effect of a high fiber diet on Volatile Organic Compound profiles after 8 hours
Time Frame: 8 hours
Volatile organic compound profiles 8 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
8 hours
Gastrointestinal pH after a 3-day low fiber diet
Time Frame: 5 weeks
Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day low fiber diet
5 weeks
Gastrointestinal pH after a 3-day high fiber diet
Time Frame: 5 weeks
Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day high fiber diet
5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal Volatile Organic Compound profiles
Time Frame: 1 week
Changes in fecal Volatile Organic Compound profiles produced during fecal fermentation, comparison of baseline (0 hours) profiles with profiles at 24 hours
1 week
SCFA
Time Frame: 1 Week
Changes in SCFA levels produced during fecal fermentation, comparison of baseline (0 hours) levels with levels at 24 hours
1 Week
Microbial enzymatic activity
Time Frame: 1 week
Changes in microbial enzymatic activity during fecal fermentation, comparison of baseline (0 hours) activity with activity at 24 hours
1 week
Microbiota composition
Time Frame: 1 week
Microbiota composition at baseline (0 hours) compared with composition at 24 hours
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Robert Brummer, Professor, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 25, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-00408-01
  • 101161484 (Other Grant/Funding Number: European Innovation Council (EIC))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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