Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

NCT ID: NCT02289612

Last Updated: 2018-05-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.

Detailed Description

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The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. To accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tapioca Starch - Low-Fibre

Tapoica starch pudding without added fibre

Group Type PLACEBO_COMPARATOR

Yellow Mustard Gum Fibre

Intervention Type OTHER

High Maltose Corn Syrup - Low-Fibre

High maltose corn syrup pudding without added fibre

Group Type PLACEBO_COMPARATOR

Yellow Mustard Gum Fibre

Intervention Type OTHER

Trutol Glucose Beverage (#1)

Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit.

Group Type PLACEBO_COMPARATOR

Yellow Mustard Gum Fibre

Intervention Type OTHER

Trutol Glucose Beverage (#2)

Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit.

Group Type PLACEBO_COMPARATOR

Yellow Mustard Gum Fibre

Intervention Type OTHER

Yellow Mustard Gum Fibre - Tapioca Starch

Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.

Group Type ACTIVE_COMPARATOR

Yellow Mustard Gum Fibre

Intervention Type OTHER

Yellow Mustard Gum Fibre - High Maltose Corn Syrup

Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.

Group Type ACTIVE_COMPARATOR

Yellow Mustard Gum Fibre

Intervention Type OTHER

Soluble Flaxseed Gum Fibre - Tapioca Starch

Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.

Group Type ACTIVE_COMPARATOR

Soluble Flaxseed Gum Fibre

Intervention Type OTHER

Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup

Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.

Group Type ACTIVE_COMPARATOR

Soluble Flaxseed Gum Fibre

Intervention Type OTHER

Fenugreek Gum Fibre - Tapioca Starch

Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.

Group Type ACTIVE_COMPARATOR

Fenugreek Gum Fibre

Intervention Type OTHER

Fenugreek Gum Fibre - High Maltose Corn Syrup

Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.

Group Type ACTIVE_COMPARATOR

Fenugreek Gum Fibre

Intervention Type OTHER

Interventions

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Yellow Mustard Gum Fibre

Intervention Type OTHER

Soluble Flaxseed Gum Fibre

Intervention Type OTHER

Fenugreek Gum Fibre

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men/Women
* Age 18-70 years
* CANRISK Questionnaire score ≥21 (brief questionnaire that identifies risk of diabetes)
* BMI ≥25 and \<40 kg/m2
* Prior use of acetaminophen

Exclusion Criteria

* Smokers
* Food allergies or any life-threatening allergy (food or otherwise)
* Acetaminophen allergy
* Gastrointestinal conditions or illnesses (Including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD))
* Serious major medical condition (i.e. renal, liver)
* Pregnant or breastfeeding
* Food Neophobia Scale score between 30 and 54 (Food Neophobia Scale is a questionnaire which is intended to screen out individuals who are unsure of consuming new products)
* TFEQ-CR \>16 (TFEQ is a questionnaire to screen for restrained eaters)
* Alcohol consumption\>4 drinks/sitting
* Medication or natural health products (NHPs) used for diabetes (glycemic control)
* Medication or NHPs contraindicated with acetaminophen
* Recent or intended significant weight loss or gain (i.e. \>4 kg in previous 3 months)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Ministry of Agriculture, Food and Rural Affairs

OTHER_GOV

Sponsor Role collaborator

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

Dairy Farmers of Ontario

OTHER

Sponsor Role collaborator

Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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Alison Duncan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison M Duncan, Ph.D., R.D.

Role: PRINCIPAL_INVESTIGATOR

University of Guelph, Human Nutraceutical Research Unit

Amanda J Wright, Ph.D.

Role: STUDY_DIRECTOR

University of Guelph, Human Nutraceutical Research Unit

Alison M Duncan, Ph.D., R.D.

Role: STUDY_DIRECTOR

University of Guelph, Human Nutraceutical Research Unit

Locations

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Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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200603

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14AP003

Identifier Type: -

Identifier Source: org_study_id

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