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

7 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

28

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Experimental: 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
Experimental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Intensity of gastrointestinal symptoms, total score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Composition and function of gut microbiome
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Dietary intake
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

17 de agosto de 2026

Conclusão Primária (Estimado)

30 de setembro de 2026

Conclusão do estudo (Estimado)

30 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • FIBRE-MATCH Helsinki Pilot
  • 101161484 (Número de outro subsídio/financiamento: European Innovation Council (EIC))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Data sharing in agreement with the EU General Data Protection Regulation

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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