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

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.