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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2014 by Vladimir Vuksan, St. Michael's Hospital, Toronto.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Vladimir Vuksan, St. Michael's Hospital, Toronto

ClinicalTrials.gov Identifier:

NCT01657058

First received: August 1, 2012

Last updated: March 6, 2014

Last verified: March 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Healthy	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: Soluble viscous fibre blend premixed with ½ carbohydrate gel Dietary Supplement: No soluble viscous fibre blend, ½ carbohydrate jello	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Dietary Fiber

U.S. FDA Resources

Further study details as provided by Vladimir Vuksan, St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Postprandial glycemia [ Time Frame: 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:

Satiety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment:	20
Study Start Date:	July 2012
Estimated Study Completion Date:	October 2014
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment # 1 Soluble viscous fibre blend powder in hydrophobic matrix	Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrix 5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
Experimental: Treatment # 2 Soluble viscous fibre blend in pre hydrated form	Dietary Supplement: Soluble viscous fibre blend in pre hydrated form 0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
Placebo Comparator: Control # 1 No soluble viscous fibre blend	Dietary Supplement: No soluble viscous fibre blend 0g soluble viscous fibre blend margarine + white bread + jello
Experimental: Treatment # 3 Soluble viscous fibre blend premixed with ½ carbohydrate gel	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
Placebo Comparator: Control # 2 No soluble viscous fibre blend, ½ carbohydrate jello	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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01657058

Locations


Canada, Ontario
St.Michael's Hospital
Toronto, Ontario, Canada

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators


Principal Investigator:	Vladimir Vuksan	St. Michael's Hospital, Toronto

More Information


Responsible Party:	Vladimir Vuksan, Professor, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01657058 History of Changes
Other Study ID Numbers:	12-147
Study First Received:	August 1, 2012
Last Updated:	March 6, 2014

Keywords provided by Vladimir Vuksan, St. Michael's Hospital, Toronto:


soluble fiber second meal effect glycemia satiety Individuals

Additional relevant MeSH terms:


Dimenhydrinate Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents	Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 22, 2017

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