Status:
COMPLETED
The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health
Lead Sponsor:
Monash University
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are: * what is the the rate of ga...
Detailed Description
To understand the role and stability of food derived bacteria in impacting microbiome composition, 20 healthy participants will be recruited for this single site double blinded randomised controlled c...
Eligibility Criteria
Inclusion
- Have no genetic conditions (e.g. Prader Willi or Down's Syndrome)
- Not diagnosed with a significant medical conditions (e.g. irritable bowel syndrome, inflammatory bowel disease or type 1/2 diabetes)
- Do not require drug-therapy (e.g. steroids or insulin or antibiotics)
- Not taking dietary supplements, probiotics, prebiotics, symbiotics or fibre supplementation
- Any condition that will affect participation in the study
- Not pregnant, planning a pregnancy or breastfeeding
- Able to complete a two-month dietary study and agree to eating all meals provided
- Have no dietary allergies or dietary restrictions that prevent consumption of provided study meals
- Open bowels regularly - mostly daily
- Able to read, write and understand English
Exclusion
- Dietary concerns identified by dietitian
- Aged less than 18 years and older than 65 years
- Diagnosed with a medical condition that requires drug therapy
- Taking medications or supplements known to alter gastrointestinal microbiota
- Women who are pregnant, planning a pregnancy or breastfeeding
- Anyone with a diagnosed gastrointestinal condition/disease e.g. irritable bowel syndrome or inflammatory bowel disease
- Known dietary allergy and/or intolerance, follows a vegan or vegetarian diet, or has coeliac disease
- Anyone with a preference for specific food avoidance or exclusion of certain ingredients in habitual diet
- Unable to tolerate blood collection procedures
- Unable to provide regular stool samples throughout the study
Key Trial Info
Start Date :
June 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05986955
Start Date
June 16 2023
End Date
November 28 2023
Last Update
April 24 2025
Active Locations (1)
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1
BASE Facility
Notting Hill, Victoria, Australia, 3168