Trial Review

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
ACTRN12621000078853
Ethics application status
Approved
Date submitted
7/12/2020
Date registered
29/01/2021
Date last updated
12/12/2022
Date data sharing statement initially provided
29/01/2021
Date results information initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty, Ageing and Inflammation Trial for Health: Effect of Fibre and Antioxidant Supplementation on Inflammation
Scientific title
Frailty, Ageing and Inflammation Trial for Health: Effect of Fibre and Antioxidant Supplementation on Inflammation in Older Adults
Secondary ID [1] 302965 0
NIL Known
Universal Trial Number (UTN)
U1111-1262-4229
Trial acronym
FAITH
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
ageing
 320010 0
frailty 320011 0
inflammation 320012 0
Condition category
Condition code
Inflammatory and Immune System 318184 318184 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
164 patients will be randomised to one of 4 groups (1:1:1:1) to receive:

- Bioceuticals Prebiome Fibre only (5g powder/twice per day) (Group A) for 16 weeks;

We advise to mix this product into food such as a smoothie, yoghurt, cereal, porridge or mashed fruit. Please also drink 250ml of water close to the same time as taking the Prebiome Fibre supplement. Please make sure that you drink at least 1500ml of fluid per day of which 500 ml is water.

- Blackmores Grapeseed Forte only (2 tablets/day) (Group B) for 16 weeks;

This is to be taken by participants at 2 Tablets once per day with food. This is the same instructions as what stated on the bottle.

- Prebiome Fibre (5g powder/twice per day) and Blackmores Grapeseed Forte (2 tablets/day) (Group C) for 16 weeks;

We advise to mix Prebiome Fibre into food such as a smoothie, yoghurt, cereal, porridge or mashed fruit. Please also drink 250ml of water close to the same time as taking the Prebiome Fibre supplement. Please make sure that you drink at least 1500ml of fluid per day of which 500 ml is water.
Grapeseed Forte is to be taken by participants at 2 Tablets once per day with food. This is the same instructions as what stated on the bottle.



Participants will be contacted by the research team to check how they are progressing and they will request that participants are to take a photograph with their mobile phone or camera of the packaging of the supplement to see how much is left and send to the research team, so participants should not throw out any empty jars. This is how monitoring will take place.
Intervention code [1] 319256 0
Treatment: Other
Comparator / control treatment
Control/ Nil Intervention (Group D). No intervention - to continue living life as normal
Control group
Active

Outcomes
Primary outcome [1] 325944 0
The primary outcome is a change in high sensitivity C Reactive Protein (CRP), an inflammatory biomarker, between pre (Baseline) and post treatment. Blood serum samples from participants will be taken to determine CRP at baseline and at post treatment time points.
Timepoint [1] 325944 0
baseline and post intervention which is 16 weeks in duration
Secondary outcome [1] 389628 0
Change in other inflammatory biomarkers including IL-6, IL-8, MCP-1, IL-10 and TNF-Alpha to be assessed via blood serum samples

Timepoint [1] 389628 0
baseline and post intervention which is 16 weeks in duration
Secondary outcome [2] 390354 0
Quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [2] 390354 0
baseline and post intervention which is 16 weeks in duration
Secondary outcome [3] 390355 0
Frailty assessed using the FRAIL scale
Timepoint [3] 390355 0
baseline and post intervention which is 16 weeks in duration

Eligibility
Key inclusion criteria
1. Male and female patients 60-70 (inclusive) years of age
2. The participant is able and willing to comply with the requirements of this trial protocol.
3. Sufficient English to answer study questionnaires
4. Willing to maintain existing diet and exercise patterns for the duration of the Trial
5. Voluntarily provided signed Informed Consent before any trial-related procedures are performed.
Minimum age
60 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Age of under 60 years or over 70 years
2. History of Inflammatory Bowel Disease, Irritable Bowel Syndrome or other bowel disease
3. History of Diabetes requiring Insulin for management
4. History of Cognitive Impairment and/or Dementia
5. Frailty
6. Already taking fibre or antioxidant supplements
7. Known allergies to berries, guar gum or other fibre supplements or grapes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to treatments by stratified block randomisation. Because we expect both individual participants and partnered people (e.g. a married couple) to be recruited, randomisation schedules will be created separately for individuals and couples. We will use blocks of size 4 or 8, randomly determined. In the couples stratum, the unit of randomisation is the couple and both members of the couple will be allocated to the same treatment. Randomisation schedules will be created by an independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to find the supplement1 * supplement 2 interaction in the decrease in CRP with 80% power, we would require 32 people in each group. However, since we are expecting that 25% of our participants will be part of a couple, we have to increase our sample size based on the effective N, accounting for clustering.
Assuming a within-cluster correlation of 0.1, the effective sample size is: neff=n / (1 + (n-1) icc)
Neff = = 32 / (1+(1)*.1) = 29
So, to achieve 32 in each group, then, we should recruit 3 more in each group, for N=35 or 140 in total.
Finally, to account for 15% attrition, a total of 164 people should be recruited
Sample size statement: We hypothesize that those in the group receiving both supplements will show larger
decreases in CRP multiplicatively than those in the other groups. In order to detect the Supplement 1 * Supplement 2 interaction, assuming 80% power and alpha=0.05, we would require 32 in each group (128 participants in total). However, because we intend to recruit couples as well as single people and account for expected attrition over the trial, we must increase the sample size. Assuming a within-couple correlation of 0.10 and 25% of the sample will be couples,
we would need to recruit a total of 140 participants. To account for expected 15% attrition, we will recruit a total of 164 people.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2021
Actual
31/03/2021
Date of last participant enrolment
Anticipated
1/08/2022
Actual
2/08/2022
Date of last data collection
Anticipated
30/12/2022
Actual
11/12/2022
Sample size
Target
164
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32159 0
2031 - Randwick
Recruitment postcode(s) [2] 32161 0
2217 - Kogarah
Recruitment postcode(s) [3] 32162 0
2232 - Sutherland

Funding & Sponsors
Funding source category [1] 307384 0
University
Name [1] 307384 0
Ageing Futures Institute, University of NSW
Country [1] 307384 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 308042 0
None
Name [1] 308042 0
Address [1] 308042 0
Country [1] 308042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307471 0
UNSW Human Research Ethics Committee B
Ethics committee address [1] 307471 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 307471 0
Australia
Date submitted for ethics approval [1] 307471 0
06/10/2020
Approval date [1] 307471 0
27/11/2020
Ethics approval number [1] 307471 0
HC200810

Summary
Brief summary
This study is a randomised controlled open labelled pilot trial. The research study aims to explore the effect of fibre and antioxidant supplementation on values of inflammation found in blood and the microbiome on older adults living in the community aged 60-70 years old.
This pilot trial is significant because the researchers hope the results of this trial will provide initial evidence of the effect of nutritional supplements on the health status of older Australians especially in relation to nutrition, inflammation and frailty.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107346 0
Dr Adrienne Withall
Address 107346 0
University of NSW
School of Population Health, Samuels Building,
Kensington, NSW 2052
Country 107346 0
Australia
Phone 107346 0
+61 02 93859428
Fax 107346 0
Email 107346 0
[email protected]
Contact person for public queries
Name 107347 0
Ms Milena Katz
Address 107347 0
University of NSW
School of Population Health, Samuels Building,
Kensington, NSW 2052
Country 107347 0
Australia
Phone 107347 0
+61 402385835
Fax 107347 0
Email 107347 0
[email protected]
Contact person for scientific queries
Name 107348 0
Ms Milena Katz
Address 107348 0
University of NSW
School of Population Health, Samuels Building,
Kensington, NSW 2052
Country 107348 0
Australia
Phone 107348 0
+61 402385835
Fax 107348 0
Email 107348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
pilot study and ethics not approved for IPD sharing without additional ethics approval.


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
No additional documents have been identified.