Soluble Fibre Enriched CHO Food Study

NCT ID: NCT01898026

Last Updated: 2014-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PGX

samples of white bread, mashed potatoes, muffin, hot breakfast cereal with the addition of soluble fibre blend

Group Type EXPERIMENTAL

Bread

Intervention Type DIETARY_SUPPLEMENT

Samples of white bread, with or without the addition of PGX fibre blend

Mashed Potatoes

Intervention Type DIETARY_SUPPLEMENT

samples of mashed potatoes, with or without the addition of soluble fibre blend

Muffins

Intervention Type DIETARY_SUPPLEMENT

Samples of muffins, with or without the addition of PGX fibre blend

Hot Breakfast Cereal

Intervention Type DIETARY_SUPPLEMENT

Samples of hot breakfast cereal without the addition of soluble fibre blend

Control

samples of white bread, mashed potatoes, muffin, hot breakfast cereal without the addition of soluble fibre blend

Group Type OTHER

Bread

Intervention Type DIETARY_SUPPLEMENT

Samples of white bread, with or without the addition of PGX fibre blend

Mashed Potatoes

Intervention Type DIETARY_SUPPLEMENT

samples of mashed potatoes, with or without the addition of soluble fibre blend

Muffins

Intervention Type DIETARY_SUPPLEMENT

Samples of muffins, with or without the addition of PGX fibre blend

Hot Breakfast Cereal

Intervention Type DIETARY_SUPPLEMENT

Samples of hot breakfast cereal without the addition of soluble fibre blend

Interventions

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Bread

Samples of white bread, with or without the addition of PGX fibre blend

Intervention Type DIETARY_SUPPLEMENT

Mashed Potatoes

samples of mashed potatoes, with or without the addition of soluble fibre blend

Intervention Type DIETARY_SUPPLEMENT

Muffins

Samples of muffins, with or without the addition of PGX fibre blend

Intervention Type DIETARY_SUPPLEMENT

Hot Breakfast Cereal

Samples of hot breakfast cereal without the addition of soluble fibre blend

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Vladimir Vuksan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's & University of Toronto

Locations

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St. Michael's

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-379C

Identifier Type: OTHER

Identifier Source: secondary_id

White Line

Identifier Type: -

Identifier Source: org_study_id

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