Soluble Fibre Enriched CHO Food Study

Development of Palatable Soluble Fibre Containing Carbohydrate Foods and Its Effects on Postprandial Blood Glucose Response in Healthy Individuals

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.

Study Overview

• Status: Unknown
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Dietary supplement: Bread; Dietary supplement: Mashed Potatoes; Dietary supplement: Muffins; Dietary supplement: Hot Breakfast Cereal

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5BW8
      • St. Michael's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PGX; samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend	Dietary supplement: Bread; Samples of white bread, with or without the addition of PGX fibre blend; Dietary supplement: Mashed Potatoes; samples of mashed potatoes, with or without the addition of soluble fibre blend; Dietary supplement: Muffins; Samples of muffins, with or without the addition of PGX fibre blend; Dietary supplement: Hot Breakfast Cereal; Samples of hot breakfast cereal without the addition of soluble fibre blend
Other: Control; samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend	Dietary supplement: Bread; Samples of white bread, with or without the addition of PGX fibre blend; Dietary supplement: Mashed Potatoes; samples of mashed potatoes, with or without the addition of soluble fibre blend; Dietary supplement: Muffins; Samples of muffins, with or without the addition of PGX fibre blend; Dietary supplement: Hot Breakfast Cereal; Samples of hot breakfast cereal without the addition of soluble fibre blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Evaluation	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.	1 month
Postprandial Glycemia	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety Score	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety will monitored using a symptoms questionnaire.	3 montsh

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Vladimir Vuksan, PhD, St. Michael's & University of Toronto

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2014
• Last Update Submitted That Met QC Criteria: February 4, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: fibre; postprandial glycemia; PGX
• Other Study ID Numbers: White Line; 12-379C (Other Identifier: St. Michael's Hospital Research Ethics Board)