Viewing Study NCT06304480



Ignite Creation Date: 2024-05-06 @ 8:14 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06304480
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-05-08
First Post: 2024-02-21

Brief Title: Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome
Sponsor: University College Cork
Organization: University College Cork

Study Overview

Official Title: Effect of The Partial Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome and Clinical Health Markers
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

ScreeningRun-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

Participants continued consent to study procedures will be confirmed
Inclusionexclusion criteria will be reviewed
Concomitant medicationsupplements 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

Participants continued consent to study procedures will be confirmed
Concomitant medicationsupplements 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

Participants continued consent to study procedures will be confirmed
Concomitant medicationsupplements 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

Participants continued consent to study procedures will be confirmed
Concomitant medicationsupplements 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 Participants 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 CRFseCRFs 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 eg 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 CRFeCRF 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 andor study procedures 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 actions and for notifying the Sponsor immediately of an SAE as specified in the protocol and for notifying the Science Department for reporting to the IRBIEC 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 requirements related to the reporting of SAEs to the IRBIEC

The Monitors 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None