A Phase 1/2 interventional study of Soluble viscous fibre blend powder in hydrophobic matrix and Soluble viscous fibre blend in pre hydrated form in Healthy, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-07.
Sponsored by Unity Health Toronto · Phase 1/2, Interventional, and Treatment
Soluble, viscous fibre has been established as an effective dietary component for lowering postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been related to its ability to increase the viscosity of the intra-luminal contents of the small intestine. Hence, the proposed mechanism with which soluble fibre affects the glycemic response, dependent on the viscosity development in the gut, would require that soluble fibre be extractable from the food matrix. This, in part, may be dependent on the food matrix that the soluble fibre is incorporated in. While properties of soluble fibre and their physiological effects have been studied extensively, limited data exists on the most effective mode of administration of fibre to optimize benefits. Furthermore, there are no studies to date that have evaluated how different modes of highly viscous soluble fibre would affect the subsequent meal. Hence, we propose a research study to determine whether the form of administration, taking into consideration the carbohydrate availability of a viscous fibre blend supplement, has a significant impact on postprandial and second meal glycemic response and subjective satiety in healthy individuals.
Following a 10-12 hr overnight fast, subjects will visit the Risk Factor Modification Centre between 8:00 am and 1:00 pm. Blood pressure and anthropometric measurements, including body weight, height, and % body fat will be taken. An initial finger prick fasting blood sample will be taken and a subjective appetite questionnaire in the form of a 100 mm visual analog scale will be completed. Subsequently, one of the 5 study meals will be administered to the subject to consume over a 10-15 minute duration accompanied by 300ml of water. Subjects will then be asked to complete a palatability questionnaire. Over the following 3 hours capillary blood samples will be taken by finger pricks at 15, 30, 45, 60, 90, 120 and 180 minutes post treatment. Appetite and symptoms questionnaires will be completed at 15, 30, 45, 60, 75, 90, and 120. At 180 min, a second standardized meal will be administered, consisting of 400kcal of pizza and 200ml of water. Further finger pick blood samples will be taken at 15, 30, 45, 60 and 120 min post pizza consumption. Upon completion of the visit, subjects will be given a 24-hour symptoms questionnaire to complete at home as an additional safety measure for a 24-hour period.
Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Soluble viscous fibre blend powder in hydrophobic matrix
Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrix
Soluble viscous fibre blend in pre hydrated form
Dietary Supplement: Soluble viscous fibre blend in pre hydrated form
No soluble viscous fibre blend
Dietary Supplement: No soluble viscous fibre blend
Soluble viscous fibre blend premixed with ½ carbohydrate gel
Dietary Supplement: Soluble viscous fibre blend premixed with ½ carbohydrate gel
No soluble viscous fibre blend, ½ carbohydrate jello
Dietary Supplement: No soluble viscous fibre blend, ½ carbohydrate jello
5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
0g soluble viscous fibre blend margarine + white bread + jello
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
Postprandial glycemia
To investigate the effectiveness of soluble dietary fibre blend supplementation depending on 1) mode of administration and 2) carbohydrate incorporation on reducing postprandial glycemia when consumed with a standardized test breakfast.
Time frame: 5 hours
Satiety
To investigate the effectiveness of soluble dietary fibre blend supplementation depending on 1) mode of administration and 2) carbohydrate incorporation on subjective satiety when consumed with a standardized test breakfast. At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective appetite score.
Time frame: 5 hours
Second Meal Glycemia
To investigate the effectiveness of these different methods of administration of konjac fibre blend on postprandial glycemia of the second standardized meal.
Time frame: 2 hours
Palatability
At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective palatability score.
Time frame: 5 hours
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto