The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals (FIBRE-MATCH)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Natalie Sundberg PhD Student
- Numero di telefono: +46 704670585
- Email: natalie.sundberg@oru.se
Backup dei contatti dello studio
- Nome: Robert Brummer, Professor
- Numero di telefono: +46 738426600
- Email: Robert.Brummer@oru.se
Luoghi di studio
-
-
-
Örebro, Svezia
- Reclutamento
- Örebro university
-
Contatto:
- Natalie Sundberg
- Email: fibrematch@oru.se
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Effect of a low fiber diet on Volatile Organic Compound profiles after 4 hours
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 5 weeks
|
Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day high fiber diet
|
5 weeks
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fecal Volatile Organic Compound profiles
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 week
|
Microbiota composition at baseline (0 hours) compared with composition at 24 hours
|
1 week
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Robert Brummer, Professor, Örebro University, Sweden
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2026-00408-01
- 101161484 (Altro numero di sovvenzione/finanziamento: European Innovation Council (EIC))
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .