Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterisation of gut microbiome | Sequencing and bacterial culturing of stool samples | Day 1, 4, 7, 11 and 14 of each phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
| Participant standing height |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Sam Forster | Hudson Institue, Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BASE Facility | Notting Hill | Victoria | 3168 | Australia |
Applications made for reasonable access to de-identified study data will be made on a case-by-case basis by the study team. Data-specified appropriate analysis will be determined when required. Applications for data accessibility will be made on a case-by-case basis by study team.
Accessibility to individual participant data (IPD) and supporting information will be determined at a later date and on a case-by-case basis
Accessibility will be assessed on a case-by-case basis
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured by stadiometer
| Height will be measured on day 14 (at end of each diet phase (fortnightly)) |
| Participant weight | Measured using balance scales | Weight will be measured on day 14 (at end of each diet phase (fortnightly)) |
| Participant waist circumference | Measured using standard measuring tape | Baseline day 1 and end of each 14-day diet phase |
| Participant Hip circumference | Measured using standard measuring tape | Baseline day 1 and end of each 14-day diet phase |
| 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)) |
| Mental Health Assessment | Perceived Stress Scale survey completed by participants | Completed at day 1 and end of study (day 56) |
| 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 |
| Habitual dietary intake | Using research food diary mobile phone application | Daily throughout 14-day baseline habitual and habitual washout phases |
| Changes in physical activity levels | Using International Physical Activity Questionnaire - Short Form (IPAQ-SF) | Completed at each of each 14-day diet phase |
| Glucose levels | Blood samples collected will be assessed for glucose levels | Blood collected at baseline day 1 and day 14 of each phase (fortnightly) |
| Lipid studies | Blood samples collected will be assessed for lipid studies | Blood collected at baseline day 1 and day 14 of each phase (fortnightly) |
| 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 |
| Gastrointestinal symptomatology | Completion of Gastrointestinal Symptom Rating Scale (GSRS) | Baseline day 1 and day 14 of each diet phase (fortnightly) |
| Bowel movement | Completion of Bristol Stool Chart questionnaires | Baseline day 1 and day 14 of each diet phase (fortnightly) |
| 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) |