- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07587424
Impact of Dietary Fibre Supplementation on Gut Symptoms in Healthy Participants (KiVa)
The Effect of Dietary Fibre Supplementation on Gastrointestinal Symptoms in Healthy Participants - KiVa-trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Anne-Maria Pajari, Professor
- Número de teléfono: +358294158203
- Correo electrónico: anne-maria.pajari@helsinki.fi
Copia de seguridad de contactos de estudio
- Nombre: Maija Marttinen, PhD
- Número de teléfono: +358294158209
- Correo electrónico: maija.marttinen@helsinki.fi
Ubicaciones de estudio
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Uusimaa
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Helsinki, Uusimaa, Finlandia
- Department of Food and Nutrition, University of Helsinki
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Contacto:
- Anne-Maria Pajari, Professor
- Número de teléfono: +358294158203
- Correo electrónico: anne-maria.pajari@helsinki.fi
-
Contacto:
- Maija Marttinen, PhD
- Número de teléfono: +358294158209
- Correo electrónico: maija.marttinen@helsinki.fi
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cellulose
poorly fermentable fibre, "negative control"
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Microcrystalline cellulose; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days
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Experimental: Oat fibre
fibre-rich product from oat bran
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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
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Experimental: Rye fibre
fibre-rich product from rye bran
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intensity of gastrointestinal symptoms, total score
Periodo de tiempo: 6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.
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The composite score of the intensity of individual gastrointestinal symptoms reported on a VAS scale by the participants.
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6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.
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Intensity of stomach/ abdominal pain
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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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.
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Intensity of bloating
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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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.
|
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Intensity of stomach cramps
Periodo de tiempo: 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
Periodo de tiempo: 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.
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Intensity of borborygmus
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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Intensity of experienced borborygmus reported on a VAS scale from 0 (no symptoms) to 100 (very intense symptoms) by the participants on daily basis
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Intensity of nausea
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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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.
|
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Intensity of heartburn
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Composition and function of gut microbiome
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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Microbiota-related analyses of the collected stool samples are carried out using DNA-based methods
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Number of bowel movements
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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Number of bowel movements reported by participants on daily basis using a mobile app.
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Breath gases
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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Hydrogen and methane measured from exhaled breath samples during run-in and fibre periods.
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Fecal and blood SCFA
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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Analysis of short chain fatty acids (SCFA) from stool and blood samples
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dietary intake
Periodo de tiempo: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
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The intake of dietary fibre and nutrients calculated from food records during run-in and fibre periods.
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Physical activity
Periodo de tiempo: 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.
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6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
|
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Metabolomics from feces, blood and urine
Periodo de tiempo: 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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FIBRE-MATCH Helsinki Pilot
- 101161484 (Otro número de subvención/financiamiento: European Innovation Council (EIC))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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