Clinical trial NCT05986955: The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health
Official title: Food Derived Bacteria and Their Role in Treating Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 gastrointestinal colonisation of food derived bacteria?
* what is the contribution of food derived bacteria to gut microbiome stability?

Participants will complete a cross over feeding study of dietitian designed meals of known microbial load and will be asked to provide stool and blood samples for analysis.

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 crossover pilot trial. The study is divided into four 14 day diet phases - baseline habitual, specified diet 1, habitual washout and specified diet 2. Participants will be randomly assigned to receive a microbial or non-microbial diet in specified diet 1 phase. Each participant will then crossover to receive the alternative diet in the specified diet 2 phase. The microbial and non-microbial diets will be identical except for the removal of naturally occurring food derived bacteria in non-microbial diet. At the commencement of the study and at the end of each diet phase, participants will attend a research clinic to undergo comprehensive clinical and anthropometric assessment and dietary evaluation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Characterisation of gut microbiome
timeFrame: Day 1, 4, 7, 11 and 14 of each phase
Secondary outcomes:
measure: Participant body mass index (BMI)
timeFrame: BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
measure: Participant standing height
timeFrame: Height will be measured on day 14 (at end of each diet phase (fortnightly))
measure: Participant weight
timeFrame: Weight will be measured on day 14 (at end of each diet phase (fortnightly))
measure: Participant waist circumference
timeFrame: Baseline day 1 and end of each 14-day diet phase
measure: Participant Hip circumference
timeFrame: Baseline day 1 and end of each 14-day diet phase
measure: Resting systolic and diastolic blood pressure
timeFrame: Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))
measure: Mental Health Assessment
timeFrame: Completed at day 1 and end of study (day 56)
measure: Dietary compliance
timeFrame: Day 1 to Day 14 of specified diet 1 and diet 2 phases
measure: Habitual dietary intake
timeFrame: Daily throughout 14-day baseline habitual and habitual washout phases
measure: Changes in physical activity levels
timeFrame: Completed at each of each 14-day diet phase
measure: Glucose levels
timeFrame: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
measure: Lipid studies
timeFrame: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
measure: Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
timeFrame: End of each 14-day diet phase
measure: Gastrointestinal symptomatology
timeFrame: Baseline day 1 and day 14 of each diet phase (fortnightly)
measure: Bowel movement
timeFrame: Baseline day 1 and day 14 of each diet phase (fortnightly)
measure: End of study optional semi-structured interview
timeFrame: End of study (at least 8 weeks post-randomisation)
Other outcomes:
Locations:
city: Notting Hill
country: Australia
facility: BASE Facility
state: Victoria
Study officials:
affiliation: Hudson Institue, Monash University
name: Dr. Sam Forster
role: PRINCIPAL_INVESTIGATOR
References: