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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]

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

Condition category

Condition code

Diet and Nutrition

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]

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]

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]

Timepoints are 0, 24 hours after commencement of diet and 48 hours after commencement of diet.

Secondary outcome [1]

Nil

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3083 - Bundoora

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University

Address [1]

GPO Box 2476 Melbourne Victoria 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT University Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee (HREC)
Research and Innovation office
RMIT University
124 LaTrobe Street
Melbourne, Victoria, 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/12/2018

Ethics approval number [1]

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

A/Prof Danilla Grando

Address

School of Science RMIT University Building 223 Level 1, Bundoora Campus RMIT University Plenty Road, Bundoora, Victoria, 3083

Country

Australia

Phone

61399257135

Fax

[email protected]

Contact person for public queries

Name

Danilla Grando

Address

School of Science RMIT University Building 223 Level 1, Bundoora Campus RMIT University Plenty Road, Bundoora, Victoria, 3083

Country

Australia

Phone

61399257135

Fax

[email protected]

Contact person for scientific queries

Name

Danilla Grando

Address

School of Science RMIT University Building 223 Level 1, Bundoora Campus RMIT University Plenty Road, Bundoora, Victoria, 3083

Country

Australia

Phone

61399257135

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Available to all those reading the publication.

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?

• Available for analysis of faecal microbial population types in healthy humans.

When can requests for individual participant data be made (start and end dates)?

From:
The data will be made available at the time of publication as a table appended to the publication. It remains available in perpetuity.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Through publication of the tables of abundances of key microbial species.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Attachment
1165	Study protocol	Study-related document.docx
1166	Informed consent form	Study-related document.doc
1167	Ethical approval	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.

Trial Review

Documents added manually

Documents added automatically