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

Study Description

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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.

Condition or disease	Intervention/treatment	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

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
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
Study Start Date :	July 2012
Actual Primary Completion Date :	December 2012
Estimated Study Completion Date :	October 2014

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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.

2. 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.
3. 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.

Eligibility Criteria

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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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	August 3, 2012
Last Update Posted:	March 7, 2014
Last Verified:	March 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