Assessing the tolerability and health benefits of soluble tapioca fibre: Phase One

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.