Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000142932p
Ethics application status
Submitted, not yet approved
Date submitted
14/12/2019
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 One
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 One
Secondary ID [1] 300097 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 315714 0
Condition category
Condition code
Diet and Nutrition 313918 313918 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 314001 314001 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potential participants will be screened against the inclusion and exclusion criteria. Participants who meet the inclusion criteria will then be provided an information letter for their perusal. Subsequently, participants will then be invited to the Murdoch University Exercise Physiology Laboratory for a face-to-face meeting for the investigators to answer any questions that participants may have in addition to getting the participants’ informed consent.
Participants who consent to the study will be required to complete five conditions of varying dosages of a soluble tapioca fibre supplement (Fibresmart) over a 4-week period which will include 3 visits to the laboratory in Murdoch University.
The study consist of five randomly allocated dosage sequences of the soluble tapioca fibre supplement (Fibresmart) over a 25-day period which participants are required to consume. The supplement dosages for the intervention are 0g (placebo), 10g, 20g, 30g and 40g. Each dosage intervention will be for a duration of five days (3 days of consuming the allocated supplement dosage and a 2-day washout period prior to commencing the next allocated supplement dosage). The supplement dosages (placebo, 10g, 20g, 30g and 40g) will be pre-mixed into 250ml Pop-Tops Apple Juice bottles (Energy: 273kJ; Carbohydrates: 15.3g; Protein: <1g and; Fats: <1g) and issued to participants for consumption. 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.
Prior to commencing 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). During the same visit, and upon completion of all baseline assessments, participants will then be provided with three pre-mixed soluble fibre supplement packages for three of the dosage interventions based on their randomized allocation to be consumed over the Weeks 1 and 2. The packages will be labelled for each dosage intervention (Days 1 to 3, Days 6 to 8 and Days 11 to 13). In addition, participants will be provided and instructed on how to complete two diaries (gastrointestinal symptoms and stool characteristics diaries) which they will be asked to complete on a daily basis for the duration of Weeks 1 and 2. Upon completion of the first visit, which will take approximately one hour, participants will then be sent home to commence their first dosage intervention on the following day. For monitoring adherence purposes, participants will be required to take a picture of the empty bottles and sent it back to the study investigator at the end of each dosage intervention.
At the end of Week 2, upon the completion of the three dosage interventions and on the second day of the 2-day washout period for the third dosage intervention, participants will then be asked to return to the laboratory to complete: (i) assessments for body anthropometrics and vital signs; (ii) a 24h dietary recall; (iii) to review and collection of the two diaries and; (iv) to receive the next two sets of pre-mixed supplement packages which are to be consumed between Days 16 to 18 and Days 21 to 23, respectively. In addition, participants will be required to complete the same diaries (as per the first 3 interventions) on a daily basis for the remaining two supplement dosage interventions. Upon completion of the second visit, which will take approximately one hour, participants will then be sent home to commence their fourth dosage intervention on the following day. For monitoring adherence purposes, participants will be required to take a picture of the empty bottles and sent it back to the study investigator at the end of each dosage intervention.
Upon completing the final two dosage interventions in Week 4, participants will then be asked to return to the laboratory to complete a series of assessments similar to that at baseline and to review and collect the final two sets of diaries. The third visit will take approximately one hour.
Intervention code [1] 316371 0
Lifestyle
Intervention code [2] 316372 0
Behaviour
Intervention code [3] 316450 0
Treatment: Other
Comparator / control treatment
There will be a placebo control group in Phase One 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). For this study, in a randomised order, all participants will be required to complete a placebo condition during the 28 day period.
Control group
Placebo

Outcomes
Primary outcome [1] 322305 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] 322305 0
A daily diary will be recorded for all days (total of 28 days) during the 4-week period which will include 4 different conditions.
Primary outcome [2] 322306 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] 322306 0
A daily diary will be recorded for all days (total of 28 days) during the 4-week period which will include 4 different conditions.
Primary outcome [3] 322307 0
Dietary history will be analysed using a 24h dietary recall that will be completed using a three pass method.
Timepoint [3] 322307 0
3 dietary recalls will be performed in Week 0, Week 2 and Week 4.
Secondary outcome [1] 378020 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] 378020 0
Body anthropometric assessments will be performed at the start of Week 0, Week 2 and Week 4.
Secondary outcome [2] 378022 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 [2] 378022 0
Vital signs assessments will be performed at the start of Week 0, Week 2 and Week 4.
Secondary outcome [3] 378023 0
Changes in health-related quality of life measures will be analyzed using a SF-36 (Short Form-36) questionnaire.
Timepoint [3] 378023 0
The SF-36 questionnaire will be completed at baseline (Week 0)
Secondary outcome [4] 378024 0
Changes in health-related physical activity will be analyzed using an international physical activity questionnaire (IPAQ).
Timepoint [4] 378024 0
The IPAQ questionnaire will be completed at baseline (Week 0)

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 both phases 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)
Following baseline assessments, the order that participants complete the 5 dosage conditions (Placebo, 10g, 20g, 30g and 40g) will be randomized. 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 order of the conditions which participants are required to complete the conditions of the study will be sealed in opaque envelopes and will be open prior to the participant's first supplement dosage condition 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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Phase one will be modelled using a linear mixed model using random-intercept and random-slope to allow greater inferences about tolerability in the larger population (i.e., more representative). With 12 repeated measures per person, additional covariates (~6, where dichotomising variables such as sex are considered 2) such as timing-of supplement intake, ethnicity, sex and/or, habitual intake. Changes in confidence intervals around the estimated effects will be assessed to help inform the maximal number of covariates (if modelled).

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] 304542 0
Commercial sector/Industry
Name [1] 304542 0
Advanced Ingredients
Country [1] 304542 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] 304814 0
None
Name [1] 304814 0
Address [1] 304814 0
Country [1] 304814 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304970 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 304970 0
Ethics committee country [1] 304970 0
Australia
Date submitted for ethics approval [1] 304970 0
03/12/2019
Approval date [1] 304970 0
Ethics approval number [1] 304970 0

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

Contacts
Principal investigator
Name 98810 0
A/Prof Timothy Fairchild
Address 98810 0
Department of Exercise Science
Murdoch University
90 South Street, Murdoch WA 6150
Country 98810 0
Australia
Phone 98810 0
+61 8 9360 2959
Fax 98810 0
Email 98810 0
[email protected]
Contact person for public queries
Name 98811 0
Shaun Teo
Address 98811 0
Department of Exercise Science
Murdoch University
90 South Street, Murdoch WA 6150
Country 98811 0
Australia
Phone 98811 0
+61 423 716 780
Fax 98811 0
Email 98811 0
[email protected]
Contact person for scientific queries
Name 98812 0
Shaun Teo
Address 98812 0
Department of Exercise Science
Murdoch University
90 South Street, Murdoch WA 6150
Country 98812 0
Australia
Phone 98812 0
+61 423 716 780
Fax 98812 0
Email 98812 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.