The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health

Healthy Clinical Trial

— FIG  

Official title:

Food Derived Bacteria and Their Role in Treating Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05986955
• Other study ID #: RES-21-0000-602A
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 2023
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Monash University
• Contact: Emma Saltzman
• Phone: +61439035949
• Email: emma.saltzman[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Diet
Participants will be assigned prospectively to microbial or non-microbial diet for first phase of trial and will then cross over to the alternate diet following a washout period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Monash University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterisation of gut microbiome	Sequencing and bacterial culturing of stool samples	Day 1, 4, 7, 11 and 14 of each phase
Secondary	Participant body mass index (BMI)	Assessed independently using height and weight measurements and appropriate formula	BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
Secondary	Participant standing height	Measured by stadiometer	Height will be measured on day 14 (at end of each diet phase (fortnightly))
Secondary	Participant weight	Measured using balance scales	Weight will be measured on day 14 (at end of each diet phase (fortnightly))
Secondary	Participant waist circumference	Measured using standard measuring tape	Baseline day 1 and end of each 14-day diet phase
Secondary	Participant Hip circumference	Measured using standard measuring tape	Baseline day 1 and end of each 14-day diet phase
Secondary	Resting systolic and diastolic blood pressure	Measured using digital blood pressure monitor	Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))
Secondary	Mental Health Assessment	Perceived Stress Scale survey completed by participants	Completed at day 1 and end of study (day 56)
Secondary	Dietary compliance	Measured by participant completed daily diet checklist noting the amount of food they consumed of provided meals during specific diet 1 and 2 phases	Day 1 to Day 14 of specified diet 1 and diet 2 phases
Secondary	Habitual dietary intake	Using research food diary mobile phone application	Daily throughout 14-day baseline habitual and habitual washout phases
Secondary	Changes in physical activity levels	Using International Physical Activity Questionnaire - Short Form (IPAQ-SF)	Completed at each of each 14-day diet phase
Secondary	Glucose levels	Blood samples collected will be assessed for glucose levels	Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Secondary	Lipid studies	Blood samples collected will be assessed for lipid studies	Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Secondary	Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)	Completion of Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)	End of each 14-day diet phase
Secondary	Gastrointestinal symptomatology	Completion of Gastrointestinal Symptom Rating Scale (GSRS)	Baseline day 1 and day 14 of each diet phase (fortnightly)
Secondary	Bowel movement	Completion of Bristol Stool Chart questionnaires	Baseline day 1 and day 14 of each diet phase (fortnightly)
Secondary	End of study optional semi-structured interview	Interview participants to assess challenges of adhering to study and compliance	End of study (at least 8 weeks post-randomisation)