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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2012
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 7, 2014
March 1, 2014
5 months
August 1, 2012
March 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Satiety
5 hours
Second Meal Glycemia
2 hours
Palatability
5 hours
Study Arms (5)
Treatment # 1
EXPERIMENTALSoluble viscous fibre blend powder in hydrophobic matrix
Treatment # 2
EXPERIMENTALSoluble viscous fibre blend in pre hydrated form
Control # 1
PLACEBO COMPARATORNo soluble viscous fibre blend
Treatment # 3
EXPERIMENTALSoluble viscous fibre blend premixed with ½ carbohydrate gel
Control # 2
PLACEBO COMPARATORNo soluble viscous fibre blend, ½ carbohydrate jello
Interventions
5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
0g soluble viscous fibre blend margarine + white bread + jello
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St.Michael's Hospital
Toronto, Ontario, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Vuksan
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 3, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
October 1, 2014
Last Updated
March 7, 2014
Record last verified: 2014-03