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

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glycemia	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.	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	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.	5 hours
Second Meal Glycemia	To investigate the effectiveness of these different methods of administration of konjac fibre blend on postprandial glycemia of the second standardized meal.	2 hours
Palatability	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.	5 hours

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Vladimir Vuksan, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): March 7, 2014
• Last Update Submitted That Met QC Criteria: March 6, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: satiety; second meal effect; glycemia; soluble fiber; Individuals
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Dimenhydrinate
• Other Study ID Numbers: 12-147