Clinical trial NCT01898026: Soluble Fibre Enriched CHO Food Study
Official title: Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Healthy
Keywords: PGX
fibre
postprandial glycemia
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. A sensory evaluation will be conducted in phase I to asses for differences between the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test foods from phase I.

Detailed description: Literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. White, refined products are still the choice of the general public. As such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend.

This research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response.

35 subjects will be recruited in phase I to complete a sensory evaluation on the test foods. Following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale.

An acute crossover RCT will be conducted in phase II by 10 healthy individuals. Subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.

Eligibility criteria: Inclusion Criteria:

* Normotensive (SBP\<140mmHg, DBP \<90mmHg)
* BMI 18.5 - 25 kg/m2
* Post-menopausal or not pregnant women

Exclusion Criteria:

* Allergy or sensitivity to test meals
* Swallowing difficulties
* Chronic use of medications or fibre
* GI conditions affecting stomach pH
* Must not be enrolled in another study
* History of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac /gastrointestinal disease, HIV positive or AIDS

Primary outcomes:
measure: Sensory Evaluation
timeFrame: 1 month
measure: Postprandial Glycemia
timeFrame: 3 months
Secondary outcomes:
measure: Satiety Score
timeFrame: 3 months
Other outcomes:
measure: Safety
timeFrame: 3 montsh
Locations:
city: Toronto
country: Canada
facility: St. Michael's
state: Ontario
Study officials:
affiliation: St. Michael's & University of Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
References: