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

NCT ID: NCT01657058

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment # 1

Soluble viscous fibre blend powder in hydrophobic matrix

Group Type EXPERIMENTAL

Soluble viscous fibre blend powder in hydrophobic matrix

Intervention Type DIETARY_SUPPLEMENT

5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello

Treatment # 2

Soluble viscous fibre blend in pre hydrated form

Group Type EXPERIMENTAL

Soluble viscous fibre blend in pre hydrated form

Intervention Type DIETARY_SUPPLEMENT

0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello

Control # 1

No soluble viscous fibre blend

Group Type PLACEBO_COMPARATOR

No soluble viscous fibre blend

Intervention Type DIETARY_SUPPLEMENT

0g soluble viscous fibre blend margarine + white bread + jello

Treatment # 3

Soluble viscous fibre blend premixed with ½ carbohydrate gel

Group Type EXPERIMENTAL

Soluble viscous fibre blend premixed with ½ carbohydrate gel

Intervention Type DIETARY_SUPPLEMENT

Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose

Control # 2

No soluble viscous fibre blend, ½ carbohydrate jello

Group Type PLACEBO_COMPARATOR

No soluble viscous fibre blend, ½ carbohydrate jello

Intervention Type DIETARY_SUPPLEMENT

Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose

Interventions

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Soluble viscous fibre blend powder in hydrophobic matrix

5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello

Intervention Type DIETARY_SUPPLEMENT

Soluble viscous fibre blend in pre hydrated form

0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello

Intervention Type DIETARY_SUPPLEMENT

No soluble viscous fibre blend

0g soluble viscous fibre blend margarine + white bread + jello

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

No soluble viscous fibre blend, ½ carbohydrate jello

Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Vladimir Vuksan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Vuksan

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St.Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-147

Identifier Type: -

Identifier Source: org_study_id

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