Effects of Mode of Administration of Soluble Fibre Blend on Glycemia, Appetite & Sensory Parameters

Phase 1

• Conditions: Healthy
• Interventions: Dietary Supplement: Soluble viscous fibre blend premixed with ½ carbohydrate gel; Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrix; Dietary Supplement: Soluble viscous fibre blend in pre hydrated form; Dietary Supplement: No soluble viscous fibre blend; Dietary Supplement: No soluble viscous fibre blend, ½ carbohydrate jello

• Registration Number: NCT01657058
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Primary Completion: 2012-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment # 3	Soluble viscous fibre blend premixed with ½ carbohydrate gel	Soluble viscous fibre blend premixed with ½ carbohydrate gel
Treatment # 1	Soluble viscous fibre blend powder in hydrophobic matrix	Soluble viscous fibre blend powder in hydrophobic matrix
Treatment # 2	Soluble viscous fibre blend in pre hydrated form	Soluble viscous fibre blend in pre hydrated form
Control # 1	No soluble viscous fibre blend	No soluble viscous fibre blend
Control # 2	No soluble viscous fibre blend, ½ carbohydrate jello	No soluble viscous fibre blend, ½ carbohydrate jello

Primary Outcome Measures

Name	Time	Method
Postprandial glycemia	5 hours	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.

Secondary Outcome Measures

Name	Time	Method
Satiety	5 hours	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.
Second Meal Glycemia	2 hours	To investigate the effectiveness of these different methods of administration of konjac fibre blend on postprandial glycemia of the second standardized meal.
Palatability	5 hours	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.

Trial Locations

Locations (1)

St.Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada