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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05986955




Registration number
NCT05986955
Ethics application status
Date submitted
19/07/2023
Date registered
14/08/2023

Titles & IDs
Public title
The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health
Scientific title
Food Derived Bacteria and Their Role in Treating Disease
Secondary ID [1] 0 0
RES-21-0000-602A
Universal Trial Number (UTN)
Trial acronym
FIG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Diet

Experimental: Specified Diet 1 - Microbial Diet - 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.

Active comparator: Specified Diet 2 - Non-microbial Diet - 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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterisation of gut microbiome
Timepoint [1] 0 0
Day 1, 4, 7, 11 and 14 of each phase
Secondary outcome [1] 0 0
Participant body mass index (BMI)
Timepoint [1] 0 0
BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
Secondary outcome [2] 0 0
Participant standing height
Timepoint [2] 0 0
Height will be measured on day 14 (at end of each diet phase (fortnightly))
Secondary outcome [3] 0 0
Participant weight
Timepoint [3] 0 0
Weight will be measured on day 14 (at end of each diet phase (fortnightly))
Secondary outcome [4] 0 0
Participant waist circumference
Timepoint [4] 0 0
Baseline day 1 and end of each 14-day diet phase
Secondary outcome [5] 0 0
Participant Hip circumference
Timepoint [5] 0 0
Baseline day 1 and end of each 14-day diet phase
Secondary outcome [6] 0 0
Resting systolic and diastolic blood pressure
Timepoint [6] 0 0
Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))
Secondary outcome [7] 0 0
Mental Health Assessment
Timepoint [7] 0 0
Completed at day 1 and end of study (day 56)
Secondary outcome [8] 0 0
Dietary compliance
Timepoint [8] 0 0
Day 1 to Day 14 of specified diet 1 and diet 2 phases
Secondary outcome [9] 0 0
Habitual dietary intake
Timepoint [9] 0 0
Daily throughout 14-day baseline habitual and habitual washout phases
Secondary outcome [10] 0 0
Changes in physical activity levels
Timepoint [10] 0 0
Completed at each of each 14-day diet phase
Secondary outcome [11] 0 0
Glucose levels
Timepoint [11] 0 0
Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Secondary outcome [12] 0 0
Lipid studies
Timepoint [12] 0 0
Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Secondary outcome [13] 0 0
Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
Timepoint [13] 0 0
End of each 14-day diet phase
Secondary outcome [14] 0 0
Gastrointestinal symptomatology
Timepoint [14] 0 0
Baseline day 1 and day 14 of each diet phase (fortnightly)
Secondary outcome [15] 0 0
Bowel movement
Timepoint [15] 0 0
Baseline day 1 and day 14 of each diet phase (fortnightly)
Secondary outcome [16] 0 0
End of study optional semi-structured interview
Timepoint [16] 0 0
End of study (at least 8 weeks post-randomisation)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2023
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
BASE Facility - Notting Hill
Recruitment postcode(s) [1] 0 0
3168 - Notting Hill

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Sam Forster
Address 0 0
Hudson Institue, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05986955