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Effect of Fibre Supplementation on Mixed-meal Challenge Response

NCT04829396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-08-03

No results posted yet for this study

Summary

Improving healthy physiological processes through nutritional intervention, as opposed to restoring physiology after disease occurrence, is an important new avenue for the reduction of disease burden in the population. A relatively new target for interventions is the gut microbiome. Dietary fibre is a nutritional intervention shown to alter gut microbiome and function. The present study aims to elucidate the relationship between microbiome modulation with dietary fibre and health. In order to assess health improvement, a meal challenge will be given to characterize the physiological processes and their resilience to challenge in healthy volunteers before and after microbiome modulation.

Conditions

  • Health Status

Interventions

OTHER

placebo

Powder consisting of 13 g of digestible carbohydrates with similar appearance as the investigational fibre mixture.

DIETARY_SUPPLEMENT

Fibre mixture

The study product is a fibre mixture consisting of a mix of 10 g of Acacia Gum and 3 g of carrot fibre taken p.o. o.d. in powder form for a total of approximately 10 g of dietary fibre per day.

Sponsors & Collaborators

  • Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek (TNO)

    collaborator UNKNOWN

  • Centre for Human Drug Research, Netherlands

    lead OTHER

Principal Investigators

  • M. Moerland, PhD · Centre for Human Drug Research

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2021-07-04
Completion
2021-07-04

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829396 on ClinicalTrials.gov