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

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 24, 2024 (before its estimated October 11, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 31, 2024 to Oct 11, 2024
    • Study completion date: Oct 31, 2024 to Oct 18, 2024
    • Start date changed from estimate of Jul 15, 2024 to Jun 17, 2024
  3. Notable Start date: Apr 15, 2024 to Jul 15, 2024
    • Primary and study completion dates: Jul 31, 2024 to Oct 31, 2024
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06304480
Lead Sponsor University College Cork
Collaborators: AIT Austrian Institute of Technology GmbH
Conditions
(from sponsor)
Gut Microbiome
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov