Effect of The Partial Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome and Clinical Health Markers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University College Cork
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Detailed Description
Randomised, open label, controlled, parallel study in healthy males and females.
- Screening/Run-in: 21 days
- Intervention phase: 56 days
- Follow-up phase: 14 days
- Total time: 91 days
At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:
- Participants will receive oral and written information about the study and be allowed to ask questions.
- Participants will sign the informed consent document.
- Inclusion and exclusion criteria will be reviewed.
- Demographic, health, and lifestyle data will be collected.
- Medical history will be collected.
- Prior concomitant medication will be recorded.
- Height and weight will be measured, and BMI calculated.
- Vitals (blood pressure, heart rate and temperature) will be recorded.
- Participant contraception method will be confirmed.
- A blood sample (14 mL) will be collected for safety analysis.
- For individuals of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status).
- Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect the stool sample at home, within 48 hours prior to the scheduled visit and bring it to the clinic.
- Participants will complete the food frequency questionnaire (FFQ).
- Participants will be provided with a 3-Day food diary and instructions on how to complete the document. Participants will return the completed diary at the next visit.
At Visit 2 Day -14, Participants will attend this study Visit and the following procedures will be carried out:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
Randomised, open label, controlled, parallel study in healthy males and females.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be able to give written informed consent.
- •Be between 18-55 years of age.
- •Has a BMI between >18.5 and <32.0 kg/m
- •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.
Exclusion Criteria
- •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
- •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
- •Creatinine supplements
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 60 days prior to this study.
Outcomes
Primary Outcomes
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.
Time Frame: 10 weeks
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.
Secondary Outcomes
- 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)
- To measure the effect of the meat substitution on body mass index (BMI).(8 weeks)