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NCT Number: NCT07594600

The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, Sweden

Location status: Recruiting

Location contact

Natalie Sundberg

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed informed consent obtained prior to any study-related procedures.
  • 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

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

Treatment and study plan

Low, High Fiber Diet

Other

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

High, Low Fiber Diet

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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. 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)

  7. 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

  8. 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

Other outcomes

  1. 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

  2. SCFA

    Time frame: 1 Week

    Changes in SCFA levels produced during fecal fermentation, comparison of baseline (0 hours) levels with levels at 24 hours

  3. 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

  4. Microbiota composition

    Time frame: 1 week

    Microbiota composition at baseline (0 hours) compared with composition at 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie Sundberg PhD Student

CONTACT

[email protected]

+46 704670585

Robert Brummer, Professor

CONTACT

[email protected]

+46 738426600

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • European Innovation Council
  • University of Helsinki

Registry information

Official study title

Characterization of Fiber-degrading Microbiota in Individuals Without Gastrointestinal Diseases

Acronym: FIBRE-MATCH

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 4, 2026

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.

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