Effects of Mode of Administration of Soluble Fibre Blend on Glycemia, Appetite & Sensory Parameters (FI-FORM)

Unity Health Toronto

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01657058

12-147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 5 patient groups, including a placebo group

Treatment # 1

Experimental group

Description:

Soluble viscous fibre blend powder in hydrophobic matrix

Treatment:

Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrix

Treatment # 2

Experimental group

Description:

Soluble viscous fibre blend in pre hydrated form

Treatment:

Dietary Supplement: Soluble viscous fibre blend in pre hydrated form

Control # 1

Placebo Comparator group

Description:

No soluble viscous fibre blend

Treatment:

Dietary Supplement: No soluble viscous fibre blend

Treatment # 3

Experimental group

Description:

Soluble viscous fibre blend premixed with ½ carbohydrate gel

Treatment:

Dietary Supplement: Soluble viscous fibre blend premixed with ½ carbohydrate gel

Control # 2

Placebo Comparator group

Description:

No soluble viscous fibre blend, ½ carbohydrate jello

Treatment:

Dietary Supplement: No soluble viscous fibre blend, ½ carbohydrate jello