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Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome

NCT06304480 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-09-24

No results posted yet for this study

Summary

There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods.

As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens.

Conditions

  • Gut Microbiome

Interventions

DIETARY_SUPPLEMENT

100g fermented Tofu

* Participants will consume 100 g Miso fermented tofu per day which may be consumed any way i.e. fried, grilled, baked, etc to taste or prepared from the list of recipes provided. * Participants will consume the first Study Product on the day of their Visit 3 (Day 0) and will consume their last Study Product the day prior to Visit 5 (Day 56). * Participants will be instructed to return any unused Study Product at Visit 5 (Day 56).

Sponsors & Collaborators

  • AIT Austrian Institute of Technology GmbH

    collaborator OTHER

  • University College Cork

    lead OTHER

Principal Investigators

  • Timothy Dinan · Atlantia Clinical Trials

  • Paul W O'Toole · University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2024-10-11
Completion
2024-10-18

Countries

  • Ireland

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 NCT06304480 on ClinicalTrials.gov