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Trial registered on ANZCTR

Registration number

ACTRN12617001139369

Ethics application status

Approved

Date submitted

31/07/2017

Date registered

4/08/2017

Date last updated

12/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Fibre supplementation and gut health in healthy females

Scientific title

Effect of fibre supplementation on gut microbiota in healthy females

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1199-6780

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gut microbiota

Immune system - Peripheral blood mononuclear cells

Condition category

Condition code

Inflammatory and Immune System

Normal development and function of the immune system

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Healthy subjects, 35-65 years, BMI 18-25kg/m2 will be recruited to determine which type of fibre supplement is more efficient at increasing short chain fatty acids (SCFAs) and bacterial diversity in healthy humans.

Each participant will be studied on 3 x 7 day occasions, such that over the experiment they will receive all 3 fibre supplements in random order. The 3 fibre supplements will include Fibremax (New Image), Vitafiber (Myprotein) and Inulin (Myprotein). Each 7 day fibre supplementation period will be separated by a washout period of 2 weeks.

Participants will be asked to consume daily the 34g of fibreMax, 15g of Vitafiber or 12g of Inulin supplement per day during the treatment period. Participants will be requested to consume a standardised diet where they will be asked to exclude fibre-rich foods (beans, high-fibre cereals and bars), dietary supplements, pre and probiotic foods and supplements, antibiotics and anti-inflammatory drugs throughout the protocol..

The intervention will be run by a qualified research dietitian with 5 years research experience and qualified research nutritionist with 10 years experience in running dietary interventions. Participants will be asked to keep a 4 day food diary prior to and in the last 4 days of each 7 day fibre supplementation period in addition to keeping a record of the time each fibre supplement was taken and any symptoms. Participants will also be asked to return their fibre supplements for measurement at the end of each 7 day supplementation period.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The trial is a randomised crossover-trial, each participant will take each of the 3 supplements.. The 3 fibre supplements will be compared to each other.

Control group

Active

Outcomes

Primary outcome [1]

Gut microbiome will be assessed from bacterial DNA extracted from stool sample.

Timepoint [1]

Participants will be asked to collect one stool sample in the 2 days before each supplementation period and in the last 2 days of each supplementation period.

Primary outcome [2]

Fasting serum levels of short chain fatty acids.

Timepoint [2]

Fasted serum samples will be collected prior to supplementation on day 1 of each supplementation period and the day following each 7-day supplementation period.

Primary outcome [3]

Fasting plasma immune cell populations.

Timepoint [3]

Fasted plasma samples will be collected prior to supplementation on day 1 of each supplementation period and the day following each 7-day supplementation period.

Secondary outcome [1]

Habitual diet

Timepoint [1]

Participants will be asked to keep a 6 x 4 day food diaries to record their dietary intake 4 days prior to and during the last 4 days of each 7 day fibre supplementation period.

Eligibility

Key inclusion criteria

Inclusion criteria: Healthy females, 35-65 years, BMI 18-25kg/m2

Minimum age

35 Years

Maximum age

65 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria will include pregnancy or planning pregnancy, breastfeeding, known diabetes, known unstable or untreated blood pressure or cholesterol, cardiovascular disease, chronic inflammatory conditions, medications that may interfere with metabolism, smoking, alcohol consumption above current NHMRC guidelines, allergy or intolerance to foods, irregular eating patterns or eating disorder, following a weight reducing diet, use of antibiotics 4 weeks prior to the start of the study and during the study. Individuals taking anti-inflammatory drugs will also be excluded from the study.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will be concealed. Concealment will be performed using sealed opaque numbered envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Groups will be randomized to each intervention using permuted block randomisation. One random block of 10 will be generated using the R package “blockrand”.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

30 women aged between 35-65 will be recruited. We estimate a drop-out rate of approximately 10%. If we make the assumption of a within-subject correlation of our outcome of 0.5 (SD between supplement group for acetate changes of 42), we will need 30 subjects per group to detect a difference with 80% power and a bilateral alpha risk of 5%.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2017

Actual

Date of last participant enrolment

Anticipated

1/06/2018

Actual

Date of last data collection

Anticipated

30/06/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

University

Name [1]

Medical Foundation, The University of Sydney

Address [1]

The University of Sydney
NSW, 2006

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
NSW, 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Not applicable

Address [1]

Not applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District - RPAH

Ethics committee address [1]

Research and Ethics Governance Office
RPAH Medical Centre
Suite 210A, 100 Carillion Avenue
NEWTOWN, NSW, 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/04/2017

Approval date [1]

11/07/2017

Ethics approval number [1]

Protocol No X17-0130 & HREC/17/RPAH/192

Summary

Brief summary

Gut microbiota is highly influenced by environmental factors particularly the diet and its dietary fibre content. Dietary fibre is non-digestible polysaccharide fermented by gut bacteria, subsequently releasing short chain fatty acids, critical for health. Dietary fibre promotes beneficial gut microbiota. However, the potency of different types of fibre to reshape gut microbial population and to boost the release of short chain fatty acids is unknown. While fibre is found in grains and legumes it can be hard to evaluate which type of fibre is present and how much is consumed. The aim of the current study is to test dietary fibre supplements which are affordable and easily quantifiable to determine which type of fibre supplement might be the most beneficial for gut and overall health.

30 women aged between 35-65 years will be recruited. The study will be a randomised open crossover fibre supplementation trial. Each participant will be studied on 3 occasions, such that over the experiment they will receive all 3 fibre supplements in random order.
The 3 fibre supplements will include Fibremax (New Image), Vitafiber (Myprotein) and Inulin (Myprotein). Participants will be asked to consume daily the 34g of FibreMax, 15g of Vitafiber or 12g of Inulin supplement per day during the treatment period. Participants will be requested to consume a standardised diet that excludes fibre rich foods (beans, high fibre cereals and bars), dietary supplements, pre and probiotic foods and supplements, antibiotics and anti-inflammatory drugs. Participants will attend an RPA blood collection centre where they will complete 6 x blood collections and the RPA clinic at the Charles Perkins Center on 7 occasions where they will be asked to complete 6 x stool collections and 6 x 4 d food diaries. Participants will first attend a screening interview where they will be asked to complete questionnaires on their medical history, medications, and eating behaviours. Two weeks before the start of the first supplementation period, participants will be asked to consume a standardized diet and will then to undergo 3 x 7 d fibre supplementation periods that will each be separated by 2week washout periods. The blood and stool samples will be used to measure short chain fatty acid levels, microbial diversity in response to dietary fibre supplementation.

Trial website

Not applicable

Trial related presentations / publications

Not applicable

Public notes

Contacts

Principal investigator

Name

Dr Laurence Macia

Address

Charles Perkins Centre
Building D17
The University of Sydney
Camperdown NSW 2006

Country

Australia

Phone

+61 2 8627 1975

Fax

[email protected]

Contact person for public queries

Name

Laurence Macia

Address

Charles Perkins Centre
Building D17
The University of Sydney
Camperdown NSW 2006

Country

Australia

Phone

+61 2 8627 1975

Fax

[email protected]

Contact person for scientific queries

Name

Laurence Macia

Address

Charles Perkins Centre
Building D17
The University of Sydney
Camperdown NSW 2006

Country

Australia

Phone

+61 2 8627 1975

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Gut-derived acetate promotes B10 cells with anti-inflammatory effects	2021	https://doi.org/10.1172/jci.insight.144156
Embase	Functional profiling of gut microbial and immune responses toward different types of dietary fiber: a step toward personalized dietary interventions.	2023	https://dx.doi.org/10.1080/19490976.2023.2274127

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically