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

NCT05986955 | Completed Early Phase 1 DMC

• 1 other identifier: RES-21-0000-602A
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Characterisation of gut microbiome

  Sequencing and bacterial culturing of stool samples

  Day 1, 4, 7, 11 and 14 of each phase

Secondary Outcomes (16)

• Participant body mass index (BMI)

  BMI will be calculated on day 14 (at end of each diet phase (fortnightly))

• Participant standing height

  Height will be measured on day 14 (at end of each diet phase (fortnightly))

• Participant weight

  Weight will be measured on day 14 (at end of each diet phase (fortnightly))

• Participant waist circumference

  Baseline day 1 and end of each 14-day diet phase

• Participant Hip circumference

  Baseline day 1 and end of each 14-day diet phase

Study Arms (2)

Specified Diet 1 - Microbial Diet

EXPERIMENTAL

Participants provided with a typical Australian diet including all food groups as described by the Australian Guide to Healthy Eating without any dietary exclusions. Meals have been designed by researchers and dietitians and prepared by professional chefs.

Other: Diet

Specified Diet 2 - Non-microbial Diet

ACTIVE COMPARATOR

Diet provided to participants is identical to Specified Diet 1 however after cooking and packaging, food for this arm will be sterilised by irradiation in line with International Organisation for Standardisation (ISO) standards and Australian code of good manufacturing practice.

Other: Diet

Interventions

Diet OTHER

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.

Specified Diet 1 - Microbial Diet; Specified Diet 2 - Non-microbial Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unable to tolerate blood collection procedures
• Unable to provide regular stool samples throughout the study

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

BASE Facility

Notting Hill, Victoria, 3168, Australia

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Dr. Sam Forster

  Hudson Institue, Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 14, 2023
• Study Start: June 16, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Accessibility to individual participant data (IPD) and supporting information will be determined at a later date and on a case-by-case basis
• Access Criteria: Accessibility will be assessed on a case-by-case basis

Locations

AU (1)