Overview

This trial is active, not recruiting.

Condition healthy
Treatments soluble viscous fibre blend powder in hydrophobic matrix, soluble viscous fibre blend in pre hydrated form, no soluble viscous fibre blend, soluble viscous fibre blend premixed with ½ carbohydrate gel, no soluble viscous fibre blend, ½ carbohydrate jello
Phase phase 1/phase 2
Sponsor St. Michael's Hospital, Toronto
Start date July 2012
End date December 2012
Trial size 20 participants
Trial identifier NCT01657058, 12-147

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Soluble viscous fibre blend powder in hydrophobic matrix
soluble viscous fibre blend powder in hydrophobic matrix
5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
(Experimental)
Soluble viscous fibre blend in pre hydrated form
soluble viscous fibre blend in pre hydrated form
0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
(Placebo Comparator)
No soluble viscous fibre blend
no soluble viscous fibre blend
0g soluble viscous fibre blend margarine + white bread + jello
(Experimental)
Soluble viscous fibre blend premixed with ½ carbohydrate gel
soluble viscous fibre blend premixed with ½ carbohydrate gel
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
(Placebo Comparator)
No soluble viscous fibre blend, ½ carbohydrate jello
no soluble viscous fibre blend, ½ carbohydrate jello
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose

Primary Outcomes

Measure
Postprandial glycemia
time frame: 5 hours

Secondary Outcomes

Measure
Satiety
time frame: 5 hours
Second Meal Glycemia
time frame: 2 hours
Palatability
time frame: 5 hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - age 18-65 years - normal glycemic response - BMI between 18.5 - 25 kg/m2 - peripheral systolic and diastolic blood pressure <140 mmHg and <90 mmHg, respectively. Exclusion Criteria: - Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS - allergies to any of the test products - Presence of an eating disorder - Following a restrictive dieting regime - Weight loss of >5kg in last 2 months - Smoking cigarettes - Alcohol intake >2 drinks/day - using prescription medications or Natural Health Products; - any condition which, in the opinion of the investigator might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results

Additional Information

Official title The Effects of Different Modes of Administration of Soluble Fibre on Postprandial and Second Meal Blood Glucose Response, Appetite and Sensory Parameters in Healthy Individuals
Principal investigator Vladimir Vuksan
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.