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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vladimir Vuksan, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01657058
First received: August 1, 2012
Last updated: February 21, 2013
Last verified: February 2013
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Postprandial glycemia [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: September 2013
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
Genders Eligible for Study:   Both
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
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

No publications provided

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: February 21, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013