Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000142134
Ethics application status
Approved
Date submitted
25/01/2019
Date registered
30/01/2019
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the impact of dietary change on human gut microbial communities
Scientific title
Microbial Shift Analysis to measure the impact of dietary change on human gut microbial communities
Secondary ID [1] 297213 0
Nil known
Universal Trial Number (UTN)
U1111-1227-3906
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut microbe composition 311258 0
Condition category
Condition code
Diet and Nutrition 309881 309881 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low-fibre diet (average daily approx. 18 g) versus high-fibre diet (average daily approx. 40 g). As examples of how the two diets vary:
Low-fibre/high-fibre; white rice/barley, white bread/weetbix, cantaloupe/pear, pizza/lentils, rice crackers/ryvita, lasagne/ratatouille, sponge cake/nuts
Food (intervention) prepared (provided) and delivered by researcher trained in safe-food preparation and handling. Diet designed by dietitians with a minimum of 5 years of experience.
Delivery of food is face-to-face individually. Participants will be provided with a notepad to diary any food not consumed and if additional food was consumed.
The number of times is daily for three consecutive days in the first week and repeated in the second week for a total of 6 x 15 minute visits. All participants will have the low-fibre diet in the first week and the high-fibre diet in the second week.
Intervention code [1] 313463 0
Treatment: Other
Comparator / control treatment
There are two diets being compared. Both dietary changes are compared to the baseline at day of commencement. This analysis determines positive and negative shifts from baseline.
Control group
Active

Outcomes
Primary outcome [1] 318827 0
Change in species abundance from base line at Day 1 to daily for two days following commencement of diet. The species abundance is measured by sequencing the faecal samples provided daily by the participants. The tool used is novel and is based on an algorithm that determines shift directions using a excel spread sheet. The primary outcome would be measured shifts consistent with species associated with either low-fibre or high-fibre diets.
Timepoint [1] 318827 0
Timepoints are 0, 24 hours after commencement of diet and 48 hours after commencement of diet.
Secondary outcome [1] 366169 0
Nil
Timepoint [1] 366169 0
Not required

Eligibility
Key inclusion criteria
Men and women aged between 18 and 65 years and in good health
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Pregnancy,
• A history of diabetes or other hormone diseases
• A history of abdominal surgery
• A current smoker
• Alcohol consumption exceeding more than two units of alcohol per day for men and more than one unit per day for women (regular alcohol consumption above this may be associated with adverse outcomes for gastrointestinal health)
• Currently suffering from a decreased appetite
• Currently suffering from nausea or vomiting
• Currently suffering from abdominal pain
• Currently suffering from light headedness, shakiness or weakness
• Currently suffering from any chronic condition
• Currently suffering from high blood pressure
• Current participation in a clinical trial (Note: If yes, this is only an exclusion if other trial involves taking a drug or another intervention)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Individuals will receive a low-fibre diet for 3 days in week 1 and a high fibre diet for 3 days in week 2
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study to determine whether individuals on a low-fibre diet have a negative shift (a shift to predominance of microorganisms with known associations with low-fibre diets) compared to a positive shift (a shift to predominance of microorganisms with known associations with high-fibre diets). The species showing shifts will be added and graphed as positive or negative on a graph. This simplified visualisation is being trialled to help the public understand how changing their diet either positively or negatively influences their gut communities.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2019
Actual
Date of last participant enrolment
Anticipated
12/10/2019
Actual
Date of last data collection
Anticipated
12/12/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25471 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 301762 0
University
Name [1] 301762 0
RMIT University
Country [1] 301762 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Danilla Grando
Address
School of Science, RMIT University, Bundoora Campus, GPO Box 71, Bundoora, Victoria, 3083
Country
Australia
Secondary sponsor category [1] 301506 0
None
Name [1] 301506 0
Address [1] 301506 0
Country [1] 301506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302480 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 302480 0
Human Research Ethics Committee (HREC)
Research and Innovation office
RMIT University
124 LaTrobe Street
Melbourne, Victoria, 3000
Ethics committee country [1] 302480 0
Australia
Date submitted for ethics approval [1] 302480 0
Approval date [1] 302480 0
17/12/2018
Ethics approval number [1] 302480 0
21784

Summary
Brief summary
Aims: This project is to verify a proposed new reporting tool for determining changes in human gut communities (gut microbiome) after dietary interventions.
Theory: The inclusion of fibre in the diet is associated with gut health. This is because fibre reaches the large intestine and feeds the resident microorganisms. These microorganisms in turn produce substances that benefit human health such as short-chain fatty acids. However the production of these substances varies with the types of organisms present and this in turn is dependent on the types of foods consumed. We can see these changes when different diets are consumed and these changes occur within a day of changing a diet. This gives us a valuable tool to determine which foods produce beneficial changes. However current methods of reporting changes to the microbiome are overly complex and do not provide a picture of changing gut communities that is readably visualised or rendered in a format understandable to lay persons wishing to understand how the foods they consume affect their gut communities.
Methodology: The current project seeks volunteers to consume low and high fibre diets and collect a swab from their first daily faecal sample. The swab will be analysed to determine the relative abundance of each type of bacteria by modern sequencing techniques. The abundance of each type of bacteria will be compared to their base line sample, collected before they start the diet, Each type of bacteria has known associations with low-fibre or high fibre and the total number of types showing positive shifts in abundance will be tallied and graphed against those showing negative shifts. It is hoped that this new simplified way of reporting changes associated with diets will help people better visualise the important benefits of changing their diet through the effects seen on changing the gut community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90366 0
A/Prof Danilla Grando
Address 90366 0
School of Science RMIT University
Building 223 Level 1, Bundoora Campus RMIT University
Plenty Road, Bundoora, Victoria, 3083
Country 90366 0
Australia
Phone 90366 0
61399257135
Fax 90366 0
Email 90366 0
[email protected]
Contact person for public queries
Name 90367 0
A/Prof Danilla Grando
Address 90367 0
School of Science RMIT University
Building 223 Level 1, Bundoora Campus RMIT University
Plenty Road, Bundoora, Victoria, 3083
Country 90367 0
Australia
Phone 90367 0
61399257135
Fax 90367 0
Email 90367 0
[email protected]
Contact person for scientific queries
Name 90368 0
A/Prof Danilla Grando
Address 90368 0
School of Science RMIT University
Building 223 Level 1, Bundoora Campus RMIT University
Plenty Road, Bundoora, Victoria, 3083
Country 90368 0
Australia
Phone 90368 0
61399257135
Fax 90368 0
Email 90368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The individual tables showing species abundances for each sample. However individuals cannot be identified from this data. Individuals will receive a simple analysis showing the number of species that have moved in a high-fibre direction or a low-fibre direction, for each time they have a dietary intervention.
When will data be available (start and end dates)?
The data will be made available at the time of publication as a table appended to the publication. It remains available in perpetuity.
Available to whom?
Available to all those reading the publication.
Available for what types of analyses?
Available for analysis of faecal microbial population types in healthy humans.
How or where can data be obtained?
Through publication of the tables of abundances of key microbial species.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1165Study protocol    376827-(Uploaded-25-01-2019-13-36-25)-Study-related document.docx
1166Informed consent form    376827-(Uploaded-25-01-2019-13-36-56)-Study-related document.doc
1167Ethical approval    376827-(Uploaded-29-01-2019-11-11-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.