Soluble Fibre Enriched CHO Food Study

Not Applicable

• Conditions: Healthy; Diabetes
• Interventions: Dietary Supplement: Bread; Dietary Supplement: Mashed Potatoes; Dietary Supplement: Muffins; Dietary Supplement: Hot Breakfast Cereal

• Registration Number: NCT01898026
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05
• Primary Completion: 2014-07
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PGX	Bread	samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend
PGX	Mashed Potatoes	samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend
PGX	Muffins	samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend
PGX	Hot Breakfast Cereal	samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend
Control	Bread	samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend
Control	Mashed Potatoes	samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend
Control	Muffins	samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend
Control	Hot Breakfast Cereal	samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend

Primary Outcome Measures

Name	Time	Method
Sensory Evaluation	1 month	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.
Postprandial Glycemia	3 months	Subjects will be randomized to consume one of the 8 interventions at each visit and blood glucose levels over 120min and satiety scores will be measured.

Secondary Outcome Measures

Name	Time	Method
Satiety Score	3 months	The incorporation of viscous soluble fibre in commonly consumed carbohydrate foods will result in increase in subjective satiety compared to non soluble fibre enriched products. Satiety will be measured using a satiety questionnaire in which you will answer four questions about how full you feel.

Trial Locations

Locations (1)

St. Michael's; 🇨🇦 Toronto, Ontario, Canada