Gut MicrobiomeNCT06304480
Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome
A study testing 100g fermented Tofu in people with Gut Microbiome, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- 100g fermented Tofu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 17 Jun 2024to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of The Partial Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome and Clinical Health Markers
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.
Read the 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:
- Participants will return the collected stool sample and will be stored for further analysis.
- Participants will be provided with a urine collection kit and instructions for collecting and storing.
- Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect stool samples at home, within 48 hours prior to the scheduled visit and bring it to the clinic.
At Visit 3 Day 0, Participants will attend this study visit, having fasted overnight for at least 10-hours and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Inclusion/exclusion criteria will be reviewed.
- Concomitant medication/supplements will be recorded.
- Vitals (blood pressure, heart rate and temperature) will be recorded.
- A fasting blood sample (10 mL) will be collected for lipids and stored for biomarker 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 return the collected stool samples and will be stored for further analysis.
- Participants will return the collected urine sample and will be stored for further analysis.
- Participant will return the 3-Day food diary.
- Participants will complete SF-36 RAND questionnaire.
Participants will be randomised into one of the two groups as follows,
- Arm 1: Intervention (replacing a portion of red meat with 100 g of fermented tofu)
- Arm 2: Control
- Participants will be supplied Study Product and instructions of dosing.
- Participants will be provided with a urine collection kit and instructions for collecting and storing.
- Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect stool samples at home, within 48 hours of the scheduled visit and bring them to the clinic.
- 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 their next visit.
- Participants will be provided with dietary advice.
At Visit 4 (Remote) Day 28: Participants will be contacted remotely on day 28 and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Concomitant medication/supplements will be recorded.
- Adverse events will be recorded.
- Participants Study Product compliance will be assessed.
At Visit 5 Day 56, Participants will attend this study visit, having fasted overnight for at least 10-hours and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Concomitant medication/supplements will be recorded.
- Vitals (blood pressure, heart rate and temperature) will be recorded.
- Adverse events will be recorded.
- A fasting blood sample (10 mL) will be collected for lipids and stored for biomarker 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 return the collected urine sample and will be stored for further analysis.
- Participants will return the collected stool samples and will be stored for further analysis.
- 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 of the scheduled visit and bring them to the clinic.
- Participant will return the 3-Day food diary.
- Participants will complete SF-36 RAND questionnaire.
- Participants will return any unused Study Product and compliance will be assessed.
Participants will return to the study site for Visit 6 (Follow-up Visit) at day 70, having completed the follow-up phase of the study. The following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Concomitant medication/supplements will be recorded.
- Adverse events will be recorded.
- Participants will return the collected stool sample and will be stored for further analysis.
Data processing \& Management Data required for the analysis will be acquired and transferred electronically to a central database by means of an Electronic Data Capture system (the "EDC-tool"). The EDC-tool will comprise an eCRF, designed specifically for the present study. High security standards for the transfer and storage of study data are guaranteed using technologies such as encrypted data transfer, firewalls, and periodic backup to protect centrally stored data. The eCRF is based on the electronic data capture system developed by Clindox, which is fully compliant with and a Gold Member of the Clinical Data Interchange Standards Consortium. The eCRF will be hosted on a dedicated validated stand-alone server placed in a double locked server room. According to the standards of the data protection law, all data obtained in the course of the study will be treated with discretion in order to guarantee the rights of the Participant's privacy.
Monitoring The responsible monitor will contact and visit the clinical site regularly and will be allowed, on request, to review the various records of the study (CRFs/eCRFs and other pertinent data) provided that Participant confidentiality is maintained in accordance with local requirements and as specified in the contract. The monitor will review the study documents (e.g., CRFs) at regular intervals throughout the study, to verify the adherence to the protocol and the legibility, completeness, consistency, and accuracy of the data being entered on them. The monitor will have access to laboratory test reports and other Participant records needed to verify the entries on the CRF/eCRF. This source data verification may be carried out remotely.
Quality assurance and quality control All Study Product used will be subjected to quality control. Quality assurance audits will be performed by the Sponsor (or any health authority) during the course of the clinical study or after its completion.
Adverse Events (AE):
For purposes of this study all AEs reported will be unexpected. The causality assessment of an AE to the investigational and/or study procedure(s) product will be rated as Unrelated, Unlikely, Possible, Probable or Definite using accepted criteria for clinical trials. The severity of AEs will be recorded, including the start and stop dates for each change in severity, and graded on a five-point-scale in accordance with the Common Terminology Criteria for Adverse Events. The outcome of AEs will be followed up and recorded. All Adverse Events (AEs) occurring during clinical studies will be recorded in the eCRF. During the study, complete reports of all AEs will be entered in the Participants site source documents, and if applicable, on the appropriate study case report forms (CRFs). A licensed clinician will be responsible for: identifying and evaluating the severity (mild, moderate, or severe) and clinical importance of the AE, taking appropriate medical action(s), and for notifying the Sponsor immediately of an SAE as specified in the protocol and for notifying the Science Department for reporting to the IRB/IEC. For any laboratory abnormality, the PI or Sub-Investigator will make a judgement as to its clinical significance. The PI or Sub-Investigator will comply with applicable regulatory requirement(s) related to the reporting of SAEs to the IRB/IEC.
The Monitor(s) will review completed CRF data and will compare CRF entries with information recorded in the source documents. Any discrepancies or omissions in either data source will be discussed with the site personnel who should make the appropriate corrections to the documents.
- Conditions
- Gut Microbiome
- Being tested
- 100g fermented Tofu
- Keywords
- Gut Microbiome, Microbiota, Plant protein, Soya protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100g fermented TofuDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: 100g fermented Tofu |
| Control | No intervention | Participants will consume their regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (6)
To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement.
Change from baseline (Week 0) to end of intervention (Week 8) in functional activity of the gut microbiome as measured by stool meta transcriptomics in a population comprising of healthy males and females.
Measured: 8 weeks
To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement.
Change from baseline (Week 0) to end of intervention (Week 8) on:
Urine metabolome (whole m/z ratio spectrum) Faecal metabolome (whole m/z ratio spectrum) Urine and Faecal metabolites will be measured using untargeted UHPLC-MS.
Measured: 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.
Change from baseline (Week 0) to end of intervention (Week 8) to measure the effect of the meat substitution on serum levels of the following inflammatory cytokines: TNF-alpha, IFN-alpha2, IL1b, IL3, IL4, IL6, IL7,IL8, IL22, CRP, CX3CL1 and Saa3 using MSD multiplex kits.
Measured: 8 weeks
To measure the effect of the meat substitution on cholesterol and serum triglycerides.
Change from baseline (Week 0) to end of intervention (Week 8) on lipid profile:
- Total cholesterol
- Triglycerides
Measured: 8 weeks
To measure the effect of the meat substitution on blood pressure.
Change from baseline (Week 0) to end of intervention (Week 8) on blood pressure [systolic/diastolic blood pressure (mmHg)].
Measured: 8 weeks
To measure the effect of the meat substitution on body mass index (BMI).
Change from baseline (Week 0) to end of intervention (Week 8) on body mass index.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start17 Jun 2024
- Primary completion11 Oct 2024 (estimated)
- Study completion18 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, open label, controlled, parallel study in healthy males and females.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- AIT Austrian Institute of Technology GmbH
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Principal investigator, Atlantia Clinical TrialsPaul W O'Toole, Study director, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304480
- Sponsor's protocol ID
- AFCRO-179
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of The Partial Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome and Clinical Health Markers
- ClinicalTrials.gov ID
- NCT06304480
- Acronym / sponsor ID
- AFCRO-179
- Conditions
- Gut Microbiome
- Keywords
- Gut Microbiome, Microbiota, Plant protein, Soya protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- AIT Austrian Institute of Technology GmbH
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 11 Oct 2024 (estimated)
- Study completion
- 18 Oct 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants will return the collected stool sample and will be stored for further analysis.
- Participants will be provided with a urine collection kit and instructions for collecting and storing.
- Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect stool samples at home, within 48 hours prior to the scheduled visit and bring it to the clinic.
At Visit 3 Day 0, Participants will attend this study visit, having fasted overnight for at least 10-hours and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Inclusion/exclusion criteria will be reviewed.
- Concomitant medication/supplements will be recorded.
- Vitals (blood pressure, heart rate and temperature) will be recorded.
- A fasting blood sample (10 mL) will be collected for lipids and stored for biomarker 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 return the collected stool samples and will be stored for further analysis.
- Participants will return the collected urine sample and will be stored for further analysis.
- Participant will return the 3-Day food diary.
- Participants will complete SF-36 RAND questionnaire.
Participants will be randomised into one of the two groups as follows,
- Arm 1: Intervention (replacing a portion of red meat with 100 g of fermented tofu)
- Arm 2: Control
- Participants will be supplied Study Product and instructions of dosing.
- Participants will be provided with a urine collection kit and instructions for collecting and storing.
- Participants will be provided with a stool collection kit and instructions for collecting and storing. Participants will collect stool samples at home, within 48 hours of the scheduled visit and bring them to the clinic.
- 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 their next visit.
- Participants will be provided with dietary advice.
At Visit 4 (Remote) Day 28: Participants will be contacted remotely on day 28 and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Concomitant medication/supplements will be recorded.
- Adverse events will be recorded.
- Participants Study Product compliance will be assessed.
At Visit 5 Day 56, Participants will attend this study visit, having fasted overnight for at least 10-hours and the following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Concomitant medication/supplements will be recorded.
- Vitals (blood pressure, heart rate and temperature) will be recorded.
- Adverse events will be recorded.
- A fasting blood sample (10 mL) will be collected for lipids and stored for biomarker 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 return the collected urine sample and will be stored for further analysis.
- Participants will return the collected stool samples and will be stored for further analysis.
- 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 of the scheduled visit and bring them to the clinic.
- Participant will return the 3-Day food diary.
- Participants will complete SF-36 RAND questionnaire.
- Participants will return any unused Study Product and compliance will be assessed.
Participants will return to the study site for Visit 6 (Follow-up Visit) at day 70, having completed the follow-up phase of the study. The following procedures will be carried out:
- Participant's continued consent to study procedures will be confirmed.
- Concomitant medication/supplements will be recorded.
- Adverse events will be recorded.
- Participants will return the collected stool sample and will be stored for further analysis.
Data processing \& Management Data required for the analysis will be acquired and transferred electronically to a central database by means of an Electronic Data Capture system (the "EDC-tool"). The EDC-tool will comprise an eCRF, designed specifically for the present study. High security standards for the transfer and storage of study data are guaranteed using technologies such as encrypted data transfer, firewalls, and periodic backup to protect centrally stored data. The eCRF is based on the electronic data capture system developed by Clindox, which is fully compliant with and a Gold Member of the Clinical Data Interchange Standards Consortium. The eCRF will be hosted on a dedicated validated stand-alone server placed in a double locked server room. According to the standards of the data protection law, all data obtained in the course of the study will be treated with discretion in order to guarantee the rights of the Participant's privacy.
Monitoring The responsible monitor will contact and visit the clinical site regularly and will be allowed, on request, to review the various records of the study (CRFs/eCRFs and other pertinent data) provided that Participant confidentiality is maintained in accordance with local requirements and as specified in the contract. The monitor will review the study documents (e.g., CRFs) at regular intervals throughout the study, to verify the adherence to the protocol and the legibility, completeness, consistency, and accuracy of the data being entered on them. The monitor will have access to laboratory test reports and other Participant records needed to verify the entries on the CRF/eCRF. This source data verification may be carried out remotely.
Quality assurance and quality control All Study Product used will be subjected to quality control. Quality assurance audits will be performed by the Sponsor (or any health authority) during the course of the clinical study or after its completion.
Adverse Events (AE):
For purposes of this study all AEs reported will be unexpected. The causality assessment of an AE to the investigational and/or study procedure(s) product will be rated as Unrelated, Unlikely, Possible, Probable or Definite using accepted criteria for clinical trials. The severity of AEs will be recorded, including the start and stop dates for each change in severity, and graded on a five-point-scale in accordance with the Common Terminology Criteria for Adverse Events. The outcome of AEs will be followed up and recorded. All Adverse Events (AEs) occurring during clinical studies will be recorded in the eCRF. During the study, complete reports of all AEs will be entered in the Participants site source documents, and if applicable, on the appropriate study case report forms (CRFs). A licensed clinician will be responsible for: identifying and evaluating the severity (mild, moderate, or severe) and clinical importance of the AE, taking appropriate medical action(s), and for notifying the Sponsor immediately of an SAE as specified in the protocol and for notifying the Science Department for reporting to the IRB/IEC. For any laboratory abnormality, the PI or Sub-Investigator will make a judgement as to its clinical significance. The PI or Sub-Investigator will comply with applicable regulatory requirement(s) related to the reporting of SAEs to the IRB/IEC.
The Monitor(s) will review completed CRF data and will compare CRF entries with information recorded in the source documents. Any discrepancies or omissions in either data source will be discussed with the site personnel who should make the appropriate corrections to the documents.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open label, controlled, parallel study in healthy males and females.
| Arm | Type | Receives |
|---|---|---|
| 100g fermented Tofu | Experimental | Dietary Supplement: 100g fermented TofuParticipants 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. |
| Control | No intervention | –Participants will consume their regular diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | 100g fermented Tofu |
Primary outcome
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.
6 secondary outcomes
To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement.
Time frame: 8 weeks
To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement.
Time frame: 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.
Time frame: 8 weeks
To measure the effect of the meat substitution on cholesterol and serum triglycerides.
Time frame: 8 weeks
To measure the effect of the meat substitution on blood pressure.
Time frame: 8 weeks
To measure the effect of the meat substitution on body mass index (BMI).
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
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SweetSpot - The Effect of Non-nutritive Sweeteners on Health
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The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dinan principal investigator
Atlantia Clinical Trials
Paul W O'Toole study director
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100g fermented Tofu in people with Gut Microbiome, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.