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

NCT06304480 | Active Not Recruiting

• 1 other identifier: AFCRO-179
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gut Microbiome; Microbiota; Plant protein; Soya protein

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of replacing animal protein in a typical Western diet with plant-derived protein delivered in a (soy-based) tofu on gut microbiome composition.

  Change from baseline (Week 0) to washout (Week 10) in gut microbiome composition as measured by shotgun metagenomics at weeks -2, 0,8 and 10.

  10 weeks

Secondary Outcomes (6)

• To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement.

  8 weeks

• To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement.

  8 weeks

• To measure the effect of the meat substitution on a panel of proinflammatory cytokines, based on the observation that particular taxa are associated with an inflammatory phenotype.

  8 weeks

• To measure the effect of the meat substitution on cholesterol and serum triglycerides.

  8 weeks

• To measure the effect of the meat substitution on blood pressure.

  8 weeks

Study Arms (2)

100g fermented Tofu

EXPERIMENTAL

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.

Dietary Supplement: 100g fermented Tofu

Control

NO INTERVENTION

Participants will consume their regular diet

Interventions

100g fermented Tofu DIETARY_SUPPLEMENT

* 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).

100g fermented Tofu

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be between 18-55 years of age.
• Has a BMI between \>18.5 and \<32.0 kg/m2.
• Has a stable body weight (≤5 % change) over the past 3-months.
• Is in general good health, as determined by the investigator.
• Consuming a single daily portion of red/processed meat in their Western diet as assessed by Food Frequency Questionnaire (meat items) at screening.
• Willing to avoid lifestyle fluctuations (diet, exercise) for the duration of the study.

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study.
• Participants who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception.
• Is hypersensitive to any of the components of the Study Product.
• Participants who have taken oral antibiotics 12 weeks prior to visit 1.
• Have a significant acute or chronic coexisting illness such as uncontrolled hypertension, uncontrolled hyperlipidaemia, hypercoagulation, inflammatory disorders, or any condition which contraindicates, in the investigator's judgement, entry to the study.
• Metabolic or chronic diseases (including pre-diabetes and diabetes), metabolic syndrome, obesity (Class 2), uncontrolled high blood pressure or chronic inflammation or any ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function.
• Participants has acute or chronic gastrointestinal and/or infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, etc.), or with a history of such diseases or gastrointestinal surgery (appendectomy in the last 3 months acceptable).
• Has a malignant disease or any concomitant end-stage organ disease, and are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, or chemotherapy or radiotherapy which, in the Investigator's judgment, contraindicates participation in the study.
• Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); alcohol/substance abuse disorder).
• Is a smoker/vaper/consumes or uses nicotine containing products.
• Taking medications/supplements that the investigator believes would interfere with the objectives of the study. Prohibited medications include:
• Metformin
• Proton pump inhibitors
• Protein supplements

Sponsors & Collaborators

• University College Cork: lead
• AIT Austrian Institute of Technology GmbH: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, T23 R50R, Ireland

Location

Study Officials

• Timothy Dinan

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

• Paul W O&#39;Toole

  University College Cork

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomised, open label, controlled, parallel study in healthy males and females.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, open label, controlled, parallel study in healthy males and females.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: June 17, 2024
• Primary Completion: October 11, 2024
• Study Completion: October 18, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)