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

1. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: Low, 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.
Sonstiges: High, Low 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Effect of a low fiber diet on Volatile Organic Compound profiles after 4 hours
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 5 weeks
Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day high fiber diet
5 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fecal Volatile Organic Compound profiles
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 week
Microbiota composition at baseline (0 hours) compared with composition at 24 hours
1 week

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Örebro University, Sweden

Mitarbeiter

University of Helsinki
European Innovation Council

Ermittler

  • Studienleiter: Robert Brummer, Professor, Örebro University, Sweden

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

25. Mai 2026

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2026-00408-01
  • 101161484 (Andere Zuschuss-/Finanzierungsnummer: European Innovation Council (EIC))

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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