Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001440819
Ethics application status
Approved
Date submitted
9/07/2021
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Date results information initially provided
25/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptance of increased daily dietary fibre in healthy participants: A preliminary feasibility study to inform a larger RCT to test the efficacy of barley on body composition and weight loss.
Scientific title
Acceptance of increased daily dietary fibre in healthy participants: A preliminary feasibility study to inform a larger RCT to test the efficacy of barley on body composition and weight loss.
Secondary ID [1] 304742 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12620000587909

The linked study is the follow on study of this feasibility study.

Health condition
Health condition(s) or problem(s) studied:
Overweight & Obesity 322786 0
Condition category
Condition code
Diet and Nutrition 320371 320371 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of three conditions at study entry: (1) Receive two daily servings of 25 gram of fibre (in the form of BARLEYmax) for 3 weeks. BARLEYmax in the form of flakes and will be added into meals i.e. breakfast cereal, desert. (FIBREmax).
(2) Receive two daily servings of BARLEYmax. However, the amount of fibre will be gradually increased over the 3 week period (week 1 = 8 gr per serving; week 2 = 16 gr per serving; week 3 = 25 gr per serving). (FIBREgrad) or (3) Placebo. Two daily servings of 25 grams placebo product in the form of flakes and will be added into meals i.e. breakfast cereal, desert.

Adherence was monitored by asking participants at end of study. How closely have you followed the use of the flakes as recommended?'
Intervention code [1] 321125 0
Treatment: Other
Intervention code [2] 321126 0
Lifestyle
Comparator / control treatment
Participants randomised into Placebo group will receive two daily servings of 25 grams of placebo product (control). Placebo will be in the form of bran flakes and will be added into meals i.e. breakfast cereal, desert.
Control group
Placebo

Outcomes
Primary outcome [1] 328213 0
Appetite & Satiety via 5-factor Hunger and Fullness Questionnaire
Timepoint [1] 328213 0
Start of study (baseline) and after week 1, week 2 & week 3.
Primary outcome [2] 328214 0
Gastrointestinal comfort via Gastrointestinal response questions developed by Chen et al. 2008.

Chen, H.L., Cheng, H.C., Wu, W.T., Liu, Y.J., & Liu, S.Y. (2008). Supplementation of konjac glucomannan into a low-fiber Chinese diet promoted bowel movement and improved colonic ecology in constipated adults: A placebo-controlled, diet-controlled trial. Journal of the American College of Nutrition, 27, 102–108.
Timepoint [2] 328214 0
Start of study (baseline) and after week 1, week 2 & week 3.
Secondary outcome [1] 398081 0
Acceptability via interview
'How acceptable were the flakes? (1-10 scale, 1 not acceptable to 10 very acceptable).'
Timepoint [1] 398081 0
End of trial - ~1 week post-intervention
Secondary outcome [2] 398083 0
Feasibility via interview
'Did you find it easy to include?
Did you find it difficult and why?'
Timepoint [2] 398083 0
End of trial - ~1 week post-intervention
Secondary outcome [3] 401961 0
Fibre intake via NHANES 26-item Dietary Screener Questionnaire
Timepoint [3] 401961 0
Start of study (baseline)

Eligibility
Key inclusion criteria
1. Aged between 18 and 50 years of age;
2. Male or female;
3. Have a body mass index between 18.5-34.9 Kg.m-2.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have a history or presence of a comorbid disease for which diet modifications may be contraindicated (e.g., diabetes, metabolic syndrome, polycystic ovary syndrome, hypoproteinemia).
2. Have a history of eating disorders.
3. Have a history of bariatric surgery.
4. Currently taking, or have taken in the last 3 months, dietary supplements for thyroid, hyperlipidemia, hypoglycaemia, or weight loss supplements (e.g., ephedra, thermogenic compounds).
5. Not have participated in a diet or clinical trial in the last 6 months.
6. Females only: pre-menopausal, menopausal, are currently pregnant or are currently breastfeeding.
7. Mental or cognitive impairment that limits ability to understand test instructions.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification by gender was undertaken, so that blocks of 12 participants were recruited at a time, Randomized into one of the three conditions of four participants each. To accommodate couples (e.g. partners/married couples) participation, Randomisation by couple took place. There will be three envelopes: one for couples, one for females and one for males. Participants were asked to pick one paper from their respective envelope and the picked paper will assign the participant to one of the conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed linear modelling for repeated measures will be used to analyse the primary and secondary outcome data. The advantage of this approach is that it can use all data irrespective of missing values. Prior to data analysis we will scan data for normality, outliers and homoscedasticity. Outliers (3 x SD) will be removed prior to analysis. If normality is violated appropriate steps will be taken (e.g. non-parametric analysis). As indicated, mixed linear modelling does not require imputation of missing data. We will consult a statistician in the instance if we have to deviate from our original analysis strategy. This is provided for free at QUT to researchers. The qualitative data (interviews and video diaries) will be transcribed verbatim and analysed using thematic analysis approach (Braun & Clark, 2006).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/10/2019
Date of last participant enrolment
Anticipated
Actual
27/11/2020
Date of last data collection
Anticipated
Actual
22/12/2020
Sample size
Target
45
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309115 0
Commercial sector/Industry
Name [1] 309115 0
The Healthy Grain Pty. Ltd.
Country [1] 309115 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St, Brisbane City QLD 4000
Country
Australia
Secondary sponsor category [1] 310064 0
University
Name [1] 310064 0
Griffith University
Address [1] 310064 0
1 Parklands Dr, Southport QLD 4215
Country [1] 310064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308984 0
Queensland University of Technology (QUT) University Human Research Ethics Committee (UHREC)
Ethics committee address [1] 308984 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Ethics committee country [1] 308984 0
Australia
Date submitted for ethics approval [1] 308984 0
06/09/2019
Approval date [1] 308984 0
04/10/2019
Ethics approval number [1] 308984 0
1900000851

Summary
Brief summary
Participants were randomised into one of three groups with different levels of fibre. This trial is a feasibility study that aimed to assess the acceptability of additional fibre in the daily diet (through BARLEYmax). This is in order to inform a larger randomised controlled trial that aims to explore the effect of increasing fibre intake on body composition and weight loss. We hypothesised that BARLEYmax would be a safe, well accepted supplement, that would increase satiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112554 0
Prof Remco Polman
Address 112554 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Country 112554 0
Australia
Phone 112554 0
+61 0731386139
Fax 112554 0
Email 112554 0
[email protected]
Contact person for public queries
Name 112555 0
Prof Remco Polman
Address 112555 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Country 112555 0
Australia
Phone 112555 0
+61 0731386139
Fax 112555 0
Email 112555 0
[email protected]
Contact person for scientific queries
Name 112556 0
Prof Remco Polman
Address 112556 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Country 112556 0
Australia
Phone 112556 0
+61 0731386139
Fax 112556 0
Email 112556 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
There is no current plan to make the individual data for the trial available as it is the intellectual property of the funder, this will be revisited at a later date


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
SourceTitleYear of PublicationDOI
EmbaseShort-Term Effect of Additional Daily Dietary Fibre Intake on Appetite, Satiety, Gastrointestinal Comfort, Acceptability, and Feasibility.2022https://dx.doi.org/10.3390/nu14194214
N.B. These documents automatically identified may not have been verified by the study sponsor.