Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000143921p
Ethics application status
Submitted, not yet approved
Date submitted
3/01/2020
Date registered
12/02/2020
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the tolerability and health benefits of soluble tapioca fibre: Phase Two
Scientific title
A pilot randomized controlled trial assessing the gastrointestinal tolerability and health benefits of Soluble Tapioca Fibre in adults with healthy gastrointestinal systems: Phase Two
Secondary ID [1] 300171 0
Nil
Universal Trial Number (UTN)
U1111-1245-4284
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Tolerability 315717 0
Condition category
Condition code
Diet and Nutrition 314003 314003 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 314004 314004 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who have completed Phase One of the study will be eligible for Phase Two of the study. Phase Two of the study will be over a 6-week period which will include three visits to the laboratory in Murdoch University and two visits to PathWest (Fiona Stanley Hospital). After a 7-day washout period, participants from Phase One will then be randomly allocated into one of the three dosage intervention groups (0g (placebo), 20g and 40g) whereby they will be required to consume their allocated soluble tapioca fibre supplement dosage daily for six weeks. Randomisation and allocation will be performed on unique study I.D.’s by an independent investigator using randomly permutated blocks (each block n = 4-6; http://www.randomisation.com). The group allocation of participants will be sealed in opaque envelopes and will be open at the completion of baseline assessments.
Prior to commencing Phase Two of the study, participants will be asked to visit the laboratory in Murdoch University to complete their baseline assessments. The preliminary measurements will include body anthropometrics (height, weight, waist circumference), vital signs (blood pressure and heart rate, dietary recall (24hr food recall), an exercise habits questionnaire (IPAQ) and a short health screen using a health-related quality of life questionnaire (SF-36). In addition to those assessments, participants will be required to: (i) complete a body composition assessment performed using a DXA scan and; (ii) report to PathWest (Fiona Stanley Hospital), for blood samples to be taken for outcome measures of the study.
During the same visit, and after the completion of all baseline assessments, participants will then be provided with three weeks’ worth (Week 1 to 3) of the pre-mixed soluble tapioca fibre supplement based on their randomly allocated dosage intervention groups (i.e. 0g (placebo), 20g, 40g) and instructed to complete the GI symptoms and stool characteristic diaries daily for the following three weeks. The supplement dosages will be pre-mixed into 250ml ‘Pop Tops Apple Juice’ bottles (Energy: 273 kJ; Carbohydrate: 15.3g; Protein: <1g and; Fats: <1g) for participants to consume. Participants will be required to consume two bottles of the pre-mixed drink twice a day for the duration of each condition. The time-points at which participants will consume the two bottles of pre-mixed drink will be 10 minutes prior to breakfast and lunch, respectively. Upon completion of the first visit, which will take approximately 1.5 hours, participants will be sent home to commence Phase Two of the study on the following day. Participants will be required to take a picture of their provided supplements at the end of each week and to send it back to the study investigator for adherence monitoring purposes.
At the end of Week 3, participants will then return to the laboratory for their second visit to complete all their assessments that are similar to that at baseline of Phase Two (excluding blood collection) and to review and collect their diaries. They will then be provided with their last three weeks’ worth (Week 4 to 6) of the pre-mixed soluble tapioca fibre supplement and instructed to complete daily diaries for GI symptoms and stool characteristics. Upon completion of the second visit, which will take approximately 1 hours, participants will be sent home to commence the last three weeks of Phase Two of study on the following day. Participants will be required to take a picture of their provided supplements at the end of each week and to send it back to the study investigator for adherence monitoring purposes.
At the end of Week 6, and at least 48 hours but not more than 72 hours, participants will be asked to return to the laboratory for their final visit whereby they will be required to complete all assessments that were similar to that at baseline of Phase Two (inclusive of blood collection at PathWest) in addition to reviewing their diaries. The third and final visit will take approximately 1.5 hours.
Intervention code [1] 316451 0
Lifestyle
Intervention code [2] 316452 0
Treatment: Other
Comparator / control treatment
There will be a placebo control group in Phase Two of the study. The placebo control will be maltodextrin supplement that contains 0g of dietary fibre pre-mixed into 250ml 'Pop Tops Apple Juice' bottles (Energy: 273kJ; Carbohydrates: 15.3g; Protein: <1g and; Fats: <1g). In Phase Two, participants may be randomised into the the placebo condition which will run for 6-weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 322411 0
Changes in gastrointestinal symptoms would be analysed using a diary. The diary will be outlined with questions related to gastrointestinal symptoms that participants are required to answer. The questions asked in the dairy are adapted from Pereira et al. (DOI: 10.1186/1471-230X-14-103) which utilised a simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation.
Timepoint [1] 322411 0
A daily diary will be recorded for all days (total of 42 days) during the 6-week period.
Primary outcome [2] 322412 0
Changes in stool characteristics would be analysed using a diary. The diary will be outlined with questions related to stool characteristics that participants are required to answer. The questions asked in the dairy are from the validated Bristol Stool Form Scale (BSFS). The BSFS is a 7-point scale used extensively in clinical practice and research for stool form measurement,
Timepoint [2] 322412 0
A daily diary will be recorded for all days (total of 42 days) during the 6-week period.
Primary outcome [3] 322413 0
Dietary history will be analysed using a 24h dietary recall that will be completed using a three pass method.
Timepoint [3] 322413 0
3 dietary recalls will be performed in Week 5, Week 8 and Week 12.
Secondary outcome [1] 378388 0
Changes in body anthropometrics would be analysed using composite measures of body mass index (calculated with height (stadiometer) and weight (digital weighing scale) and waist circumference (tape measure).
Timepoint [1] 378388 0
Body anthropometric assessments will be performed at the start of Week 5, Week 8 and at the end of Week 12.
Secondary outcome [2] 378389 0
Composite changes in body composition (body fat and lean muscle mass percentage) would be analysed using a DXA scan.
Timepoint [2] 378389 0
A DXA scan will be performed twice, which will occur at the start of Week 5 and at the end of Week 12.
Secondary outcome [3] 378390 0
Changes in vital signs would be analysed by measuring blood pressure and heart rate. Blood pressure will be measured using a Welch Allyn 767 Aneroid Sphygmomanometer with Mobile Stand and Adult Cuff. Heart rate will be measured using a SUUNTO heart rate strap and SUUNTO SPARTAN TRAINER wrist watch.
Timepoint [3] 378390 0
Vital signs assessments will be performed at the start of Week 5, Week 8 and at the end of Week 12.
Secondary outcome [4] 378391 0
Changes in health-related quality of life measures will be analyzed using a SF-36 (Short Form-36) questionnaire.
Timepoint [4] 378391 0
The SF-36 questionnaire will be completed at baseline (Week 5) and at the end of the intervention (Week 12).
Secondary outcome [5] 378392 0
Changes in health-related physical activity will be analyzed using an international physical activity questionnaire (IPAQ).
Timepoint [5] 378392 0
The IPAQ questionnaire will be completed at baseline (Week 5) and at the end of the intervention (Week 12).
Secondary outcome [6] 378393 0
Composite changes in blood chemistry and haemtology will be analyzed using fasting blood samples.
Timepoint [6] 378393 0
Blood samples collection will be completed at the baseline Week 5 and at the end of the intervention in Week 12.

Eligibility
Key inclusion criteria
Individuals without clinically diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility and agree to keep a detailed dietary for GI symptoms and stool characteristics during the study. In addition, potential participants will be required to complete Phase One of the study to be eligible for participation in Phase Two of the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals having constipation, defined as 0–3 stools per week for the last 6 weeks; prescription of medication for digestive symptoms such as anti-spasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries, relevant history/presence of any medical disorder or intake of medication/dietary supplements potentially interfering with this trial (e.g. irritable bowel syndrome), vegetarians or vegans, intake of antibiotics within 4 weeks before the screening visit and intake of laxatives within 2 weeks before the screening visit.

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)
In Phase Two, following all baseline assessments, participants will be randomly assigned into their intervention groups (Placebo, 20g and 40g). Randomisation and allocation will be performed on unique study I.D.’s by an independent investigator using randomly permutated blocks (each block n = 4-6; http://www.randomisation.com) with males and females counterbalanced (separate allocation sequences generated) across groups. The allocation of participants to their respective groups are sealed in opaque envelopes and will be open prior to the participant's first day of consuming the supplement by the study researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Phase two will be modelled as a fixed-effects (outcome measure) linear mixed model (random-intercept). Primary outcome will be the within-between interaction. Importantly, the scales are all based on 4 or more categories and will be modelled as continuous variables. Post Hoc analysis will be via an LSD.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2020
Actual
Date of last participant enrolment
Anticipated
28/09/2020
Actual
Date of last data collection
Anticipated
28/12/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304610 0
Commercial sector/Industry
Name [1] 304610 0
Advanced Ingredients
Country [1] 304610 0
United States of America
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street Murdoch, Perth Western Australia 6150
Country
Australia
Secondary sponsor category [1] 304903 0
None
Name [1] 304903 0
Address [1] 304903 0
Country [1] 304903 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305031 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 305031 0
Ethics committee country [1] 305031 0
Australia
Date submitted for ethics approval [1] 305031 0
03/12/2019
Approval date [1] 305031 0
Ethics approval number [1] 305031 0

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

Contacts
Principal investigator
Name 99034 0
A/Prof Timothy Fairchild
Address 99034 0
Department of Exercise Science
Murdoch University
90 South Street, Murdoch WA 6150
Country 99034 0
Australia
Phone 99034 0
+61 8 9360 2959
Fax 99034 0
Email 99034 0
[email protected]
Contact person for public queries
Name 99035 0
Shaun Teo
Address 99035 0
Department of Exercise Science
Murdoch University
90 South Street, Murdoch WA 6150
Country 99035 0
Australia
Phone 99035 0
+61 423 716 780
Fax 99035 0
Email 99035 0
[email protected]
Contact person for scientific queries
Name 99036 0
Shaun Teo
Address 99036 0
Department of Exercise Science
Murdoch University
90 South Street, Murdoch WA 6150
Country 99036 0
Australia
Phone 99036 0
+61 423 716 780
Fax 99036 0
Email 99036 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


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.