Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000587909p
Ethics application status
Submitted, not yet approved
Date submitted
22/04/2020
Date registered
21/05/2020
Date last updated
21/05/2020
Date data sharing statement initially provided
21/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of increased dietary fibre intake on body composition, weight loss and health
Scientific title
Efficacy of increased dietary fibre (in the form of barley) on body composition, weight loss and health in overweight and obese adults
Secondary ID [1] 301095 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight & Obesity 317169 0
Condition category
Condition code
Diet and Nutrition 315322 315322 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 daily servings of 32 grams of additional fibre for 12 weeks. (BARLEYsupermax condition); (2) Receive daily servings of 16 grams of additional fibre for 12 weeks (BARLEYmax) or (3) Placebo. Servings will be in the form of flakes and will be added into meals i.e. breakfast cereal, desert.
Intervention code [1] 317403 0
Treatment: Other
Intervention code [2] 317404 0
Lifestyle
Comparator / control treatment
Participants randomised into Placebo group will receive 16 grams of placebo product (control). Placebo will be in the form of flakes and will be added into meals i.e. breakfast cereal, desert.
Control group
Placebo

Outcomes
Primary outcome [1] 323571 0
Change in body composition as measured by DEXA
Timepoint [1] 323571 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Primary outcome [2] 323576 0
Change in body mass index as a product of height measured with stadiometer and body weight as measured by scales.
Timepoint [2] 323576 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [1] 382245 0
Food record
In the week before commencing the trial and after the 12-weeks of supplementation, participants will be asked to complete three one-day food records and a short questionnaire to assess their usual energy intake as well as intake of fibre, and other relevant micro- and macro-nutrients and foodgroups. Each food record will take approximately 20 minutes to complete and assesses what the participants drank and ate that day. Participants will be asked to download the Easy Diet Diary app to their mobile phone to record foods eaten and drinks consumed on each of the three record days. Detailed instructions will be provided on how to use this app to record foods eaten. This app is commonly used for research purposes, and is produced and supported by a local Brisbane-based company (https://xyris.com.au/). The dietary intake data recorded in the app will be transferred to the QUT researchers via the Easy Diet Diary Connect software which links to the participant’s food diary after the participant has given approval for this (via an automatic email-based approval process). A paper-based recording option will be offered to participants who are unable to use the app on a mobile phone. The food diary data will initially contain the particpants’ name for identification purposes but prior to analyses, names will be removed and replaced with the study identification number. Food diary data will be processed using the FoodWorks food composition database and statistical software.
Timepoint [1] 382245 0
In the week prior to beginning the intervention (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [2] 382246 0
Quality of Life
Participants will complete the Short-Form 36 health questionnaire (SF-36), which is an instrument that is designed to measure health status (Lins & Carvalho, 2016). This questionnaire incorporates questions from eight domains to determine health-related quality of life. (E.g. vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). The SF-36 will be completed electronically on either a laptop, tablet or phone.
Timepoint [2] 382246 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [3] 382247 0
High-sensitivity C-reactive protein will be assessed from the serum.
Timepoint [3] 382247 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [4] 382248 0
Fasting plasma glucose will be assessed from a blood sample.
Timepoint [4] 382248 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [5] 382249 0
Gut microbiota composition will be assessed from a stool sample
Timepoint [5] 382249 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [6] 382252 0
Blood lipid profile will be assessed from a blood sample.
Timepoint [6] 382252 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [7] 382254 0
Blood pressure will be assessed with a sphygmomanometer
Timepoint [7] 382254 0
At the beginning of the study (baseline) and after the 12-weeks of supplementation (final).
Secondary outcome [8] 382651 0
Acceptability, appropriateness and feasibility of the interventions will be assessed in an interview
Timepoint [8] 382651 0
After the 12 week intervention.
Secondary outcome [9] 382652 0
Appetite perceptions of consuming additional dietary fibre will be assessed in audio/video/written updates/diaries (based on individual preferences). The participant will be prompted to provide this information by answering specific questions. i.e. how was your appetite within the past week?.
Timepoint [9] 382652 0
These updates will be received weekly for the duration of the trial (weekly for 12 weeks)
Secondary outcome [10] 383054 0
Symptoms of consuming additional dietary fibre will be assessed in audio/video/written updates/diaries (based on individual preferences). The participant will be prompted to provide this information by answering specific questions. i.e. did you have any symptoms from consuming the additional fibre within the past week?.
Timepoint [10] 383054 0
These updates will be received weekly for the duration of the trial (weekly for 12 weeks)
Secondary outcome [11] 383055 0
Acceptability of consuming additional dietary fibre will be assessed in audio/video/written updates/diaries (based on individual preferences). The participant will be prompted to provide this information by answering specific questions. i.e. what was the acceptability of the intervention in the last week?
Timepoint [11] 383055 0
These updates will be received weekly for the duration of the trial (weekly for 12 weeks)

Eligibility
Key inclusion criteria
1. Aged between 18 and 50 years of age;
2. Male or female;
3. Have a body mass index between 24.9 - 34.9 Kg.m-2.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a history or presence of a comorbid disease for which diet modifications may be contraindicated (e.g., gastrointestinal diseases such as ulcerative colitis, Crohn’s disease and other inflammatory bowel diseases, irritable bowel syndrome, celiac disease, diverticulitis, polycystic ovary syndrome, hypoproteinemia).
2. Have a history of eating disorders.
3. Have a history of bariatric surgery.
4. Have a nut allergy.
5. 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).
6. Have participated in a diet or clinical trial in the last 6 months.
7. Females only: women with menopausal symptoms, women who are currently pregnant or are currently breastfeeding.
8. Mental or cognitive impairment that limits the 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)
Block randomization stratification by gender will be undertaken, so that blocks of 12 participants will be 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 will also take place. Assessors will prepare the envelopes with four paper codes (3 for each condition) which will be added to opaque not concealed envelopes. There will be three envelopes: one for couples, one for females and one for males. Participants will be asked to pick one paper from their respective envelope and the picked paper will assign the participant to one of the conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
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
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2020
Actual
Date of last participant enrolment
Anticipated
7/12/2020
Actual
Date of last data collection
Anticipated
1/03/2021
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 305536 0
Commercial sector/Industry
Name [1] 305536 0
The Healthy Grain Pty. Ltd.
Country [1] 305536 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] 305944 0
University
Name [1] 305944 0
Griffith University
Address [1] 305944 0
1 Parklands Dr, Southport QLD 4215
Country [1] 305944 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305842 0
Queensland University of Technology (QUT) University Human Research Ethics Committee (UHREC)
Ethics committee address [1] 305842 0
Ethics committee country [1] 305842 0
Australia
Date submitted for ethics approval [1] 305842 0
28/04/2020
Approval date [1] 305842 0
Ethics approval number [1] 305842 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101786 0
Prof Remco Polman
Address 101786 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Country 101786 0
Australia
Phone 101786 0
+610731386139
Fax 101786 0
Email 101786 0
[email protected]
Contact person for public queries
Name 101787 0
Remco Polman
Address 101787 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Country 101787 0
Australia
Phone 101787 0
+610731386139
Fax 101787 0
Email 101787 0
[email protected]
Contact person for scientific queries
Name 101788 0
Remco Polman
Address 101788 0
QUT Kelvin Grove campus, Victoria Park Road, Kelvin Grove QLD 4059
Country 101788 0
Australia
Phone 101788 0
+610731386139
Fax 101788 0
Email 101788 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 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
No additional documents have been identified.