Effects of Mode of Administration of Soluble Fibre Blend on Glycemia, Appetite & Sensory Parameters (FI-FORM)
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ClinicalTrials.gov Identifier: NCT01657058 |
Recruitment Status
: Unknown
Verified March 2014 by Vladimir Vuksan, St. Michael's Hospital, Toronto.
Recruitment status was: Active, not recruiting
First Posted
: August 3, 2012
Last Update Posted
: March 7, 2014
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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 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment # 1
Soluble viscous fibre blend powder in hydrophobic matrix
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Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrix
5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
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Experimental: Treatment # 2
Soluble viscous fibre blend in pre hydrated form
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Dietary Supplement: Soluble viscous fibre blend in pre hydrated form
0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
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Placebo Comparator: Control # 1
No soluble viscous fibre blend
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Dietary Supplement: No soluble viscous fibre blend
0g soluble viscous fibre blend margarine + white bread + jello
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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
|
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657058
Canada, Ontario | |
St.Michael's Hospital | |
Toronto, Ontario, Canada |
Principal Investigator: | Vladimir Vuksan | St. Michael's Hospital, Toronto |
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 Key Record Dates |
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 |