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Impact of Dietary Fibre Supplementation on Gut Symptoms in Healthy Participants (KiVa)

7 maggio 2026 aggiornato da: Anne-Maria Pajari, University of Helsinki

The Effect of Dietary Fibre Supplementation on Gastrointestinal Symptoms in Healthy Participants - KiVa-trial

Fibres found in food are mainly carbohydrates that are not broken down or absorbed during human digestion but instead pass to the colon to be fermented by microbes. Gases produced during bacterial fermentation (hydrogen, methane, and carbon dioxide), can cause unpleasant gastrointestinal symptoms in some individuals, such as bloating, flatulence, and stomach pain. Gas production varies between individuals and is influenced by the chemical structure of dietary fibres, the gut microbes' ability to ferment fibre, intestinal pH, and the transit time of intestinal contents. This randomized clinical trial in healthy adults will investigate how individual variations in the microbiome influence the level of gastrointestinal (GI) symptoms induced by different fibre types during short-term exposure.

Panoramica dello studio

Descrizione dettagliata

The objective of this dietary intervention is to examine the effects of different dietary fibre types on gastrointestinal symptoms in apparently healthy adults and to investigate how these effects relate to the composition and functional capacity of the gut microbiota.

The study is designed as a randomized, crossover intervention trial with a total duration of approximately 6 weeks. A 5-day run-in phase is carried out to stabilize baseline dietary patterns and ensure adherence to study procedures. During the intervention, each participant consumes 3 different fibre-rich products, with each product administered for 4 consecutive days (referred to as a "fibre period"). Each fibre period is separated by a 10-day washout period.

Participants (n=28) are apparently healthy adult males and females aged 18-65 years who experience gastrointestinal/ digestive discomfort during or after eating. Individuals without such symptoms are unlikely to exhibit measurable responses, which would limit the ability to address the study's primary research questions.

During the 4-day fibre period, the daily fibre dose provided by the study product is 20 g for women and 25 g for men (corresponding to 2.5 g of fibre per MJ of energy intake, assuming daily energy intake of 8 MJ for women and 10 MJ for men). During the trial, participants consume three structurally different types of dietary fibre: cellulose (poorly fermentable fibre; microcrystalline cellulose), beta-glucan rich fibre (oat bran-based fibre product), and arabinoxylan rich fibre (rye bran-based fibre product). Participants are randomly assigned into one of the six predefined intervention sequences, which represent all possible orders of exposure to the 3 fibre products. Sequence allocation will be generated prior to enrolment, and participants will receive each fibre-rich test product in a randomized order. Participants are instructed to keep the rest of their diet as habitual as possible during the study. Regular use of dietary supplements must be discontinued for the study duration

Participants report their daily GI symptoms as well as perceived stress and mood through a symptom questionnaire using a mobile app. A total of nine GI symptoms are reported (i.e., stomach/ abdominal pain, stomach cramps, bloating, flatulence, borborygmus, nausea, heartburn, discomfort in the upper abdomen/ unpleasant sensation of fullness following eating, a sudden need to defecate), and their severity of symptoms is assessed on a 0-100 VAS scale. Participants report daily the number of bowel movements through the online form, as well as their daily amount of physical activity. In addition, physical activity is assessed using an accelerometer. Dietary intake is assessed by food records (3-day food records during the run-in period and 2-day food records during each fibre period).

Stool samples are used for the analysis of the gut microbiota and metabolome. Additionally, the the effects of different fibre types on metabolic profiles in blood, urine, and stool samples (including SCFAs), as well as on gases in exhaled breath will be analysed.

Tipo di studio

Interventistico

Iscrizione (Stimato)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • healthy male and female
  • aged 18-65 years
  • experience gastrointestinal discomfort during or after eating
  • willing to commit to the 6-week study period and follow the study schedule.

Exclusion Criteria:

  • Body mass index ≤ 18.5 or ≥ 35 kg/m².
  • Inflammatory bowel diseases, irritable bowel syndrome (IBS), celiac disease, endocrine or lipid metabolism disorders, liver or kidney diseases, cancer within the past 5 years, eating disorders.
  • Medication for gastrointestinal symptoms, bowel function, diabetes, or hypercholesterolemia.
  • Regular or recent use of antibiotics (within the last 3 months).
  • Food allergies to the ingredients of the study products.
  • Heavy, long-duration exercise several times a week.
  • Smoking, use of snus or nicotine pouches.
  • Planned or ongoing pregnancy or breastfeeding.
  • In addition, the site-specific principal investigator may exclude a person due to any illness, medication, or factor they deem relevant for the participant's health and safety or for the conduct of the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cellulose
poorly fermentable fibre, "negative control"
Microcrystalline cellulose; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days
Sperimentale: Oat fibre
fibre-rich product from oat bran
Oat bran-based fibre product; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days
Sperimentale: Rye fibre
fibre-rich product from rye bran
Rye bran-based fibre product; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intensity of gastrointestinal symptoms, total score
Lasso di tempo: 6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.
The composite score of the intensity of individual gastrointestinal symptoms reported on a VAS scale by the participants.
6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of stomach/ abdominal pain
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced stomach/ abdominal pain reported on a VAS scale from zero (no pain) to 100 (very intense pain) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of bloating
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced bloatingreported on a VAS scale from zero (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of stomach cramps
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared
Intensity of experienced stomach cramps reported on a VAS scale from zero (no pain) to 100 (very intense pain) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared
Intensity of flatulence
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced flatulence reported on a VAS scale from zero (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of borborygmus
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced borborygmus reported on a VAS scale from 0 (no symptoms) to 100 (very intense symptoms) by the participants on daily basis
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of nausea
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced nausea reported on a VAS scale from 0 (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of heartburn
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced heartburn reported on a VAS scale from 0 (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of discomfort in the upper abdomen or unpleasant sensation of fullness following eating
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced discomfort or unpleasant sensation reported on a VAS scale from 0 (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of a sudden need to defecate
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Intensity of experienced discomfort or unpleasant sensation reported on a VAS scale from 0 (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composition and function of gut microbiome
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Microbiota-related analyses of the collected stool samples are carried out using DNA-based methods
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Number of bowel movements
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Number of bowel movements reported by participants on daily basis using a mobile app.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Breath gases
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Hydrogen and methane measured from exhaled breath samples during run-in and fibre periods.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Fecal and blood SCFA
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Analysis of short chain fatty acids (SCFA) from stool and blood samples
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Dietary intake
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
The intake of dietary fibre and nutrients calculated from food records during run-in and fibre periods.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Physical activity
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Level of physical activity and inactivity determined using an accelerometer during run-in and fibre periods.
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Metabolomics from feces, blood and urine
Lasso di tempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
Targeted/untargeted analysis of fecal, blood and urine metabolome
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

17 agosto 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • FIBRE-MATCH Helsinki Pilot
  • 101161484 (Altro numero di sovvenzione/finanziamento: European Innovation Council (EIC))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Data sharing in agreement with the EU General Data Protection Regulation

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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