The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 292493 0
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 304126 0
Immune system - Peripheral blood mononuclear cells 304127 0
Condition category
Condition code
Inflammatory and Immune System 303458 303458 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 303459 303459 0 0
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] 298672 0
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] 302828 0
Gut microbiome will be assessed from bacterial DNA extracted from stool sample.
Timepoint [1] 302828 0
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] 302829 0
Fasting serum levels of short chain fatty acids.
Timepoint [2] 302829 0
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] 302830 0
Fasting plasma immune cell populations.
Timepoint [3] 302830 0
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] 337179 0
Habitual diet
Timepoint [1] 337179 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8579 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 16686 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 297061 0
University
Name [1] 297061 0
Medical Foundation, The University of Sydney
Address [1] 297061 0
The University of Sydney
NSW, 2006
Country [1] 297061 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW, 2006
Country
Australia
Secondary sponsor category [1] 296068 0
None
Name [1] 296068 0
Not applicable
Address [1] 296068 0
Not applicable
Country [1] 296068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298245 0
Sydney Local Health District - RPAH
Ethics committee address [1] 298245 0
Research and Ethics Governance Office
RPAH Medical Centre
Suite 210A, 100 Carillion Avenue
NEWTOWN, NSW, 2042
Ethics committee country [1] 298245 0
Australia
Date submitted for ethics approval [1] 298245 0
26/04/2017
Approval date [1] 298245 0
11/07/2017
Ethics approval number [1] 298245 0
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 76458 0
Dr Laurence Macia
Address 76458 0
Charles Perkins Centre
Building D17
The University of Sydney
Camperdown NSW 2006
Country 76458 0
Australia
Phone 76458 0
+61 2 8627 1975
Fax 76458 0
Email 76458 0
laurence.macia@sydney.edu.au
Contact person for public queries
Name 76459 0
Dr Laurence Macia
Address 76459 0
Charles Perkins Centre
Building D17
The University of Sydney
Camperdown NSW 2006
Country 76459 0
Australia
Phone 76459 0
+61 2 8627 1975
Fax 76459 0
Email 76459 0
laurence.macia@sydney.edu.au
Contact person for scientific queries
Name 76460 0
Dr Laurence Macia
Address 76460 0
Charles Perkins Centre
Building D17
The University of Sydney
Camperdown NSW 2006
Country 76460 0
Australia
Phone 76460 0
+61 2 8627 1975
Fax 76460 0
Email 76460 0
laurence.macia@sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable