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Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products (Pudding)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Yellow Mustard Gum Fibre
Soluble Flaxseed Gum Fibre
Fenugreek Gum Fibre
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Risk for Type 2 Diabetes Mellitus, Fibre, Postprandial Glucose, Postprandial Insulin, Postprandial Acetaminophen, Satiety

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Human Nutraceutical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tapioca Starch - Low-Fibre

High Maltose Corn Syrup - Low-Fibre

Trutol Glucose Beverage (#1)

Trutol Glucose Beverage (#2)

Yellow Mustard Gum Fibre - Tapioca Starch

Yellow Mustard Gum Fibre - High Maltose Corn Syrup

Soluble Flaxseed Gum Fibre - Tapioca Starch

Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup

Fenugreek Gum Fibre - Tapioca Starch

Fenugreek Gum Fibre - High Maltose Corn Syrup

Arm Description

Tapoica starch pudding without added fibre

High maltose corn syrup pudding without added fibre

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Fasting and postprandial blood glucose response for each pudding and control product
Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Fasting and postprandial insulin response for each pudding and control product
Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Fasting and postprandial acetaminophen absorption for each pudding and control product
Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Satiety-producing effect for each pudding and control product
Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed.

Secondary Outcome Measures

3-Day food records
Participants will complete 3-day food records before the first treatment study visit to provide information about their background nutrient intake and dietary habits.

Full Information

First Posted
November 5, 2014
Last Updated
May 2, 2018
Sponsor
University of Guelph
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs, Natural Sciences and Engineering Research Council, Canada, Dairy Farmers of Ontario, Agriculture and Agri-Food Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02289612
Brief Title
Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products
Acronym
Pudding
Official Title
The Pudding Study: The Effect of Effect of Fibre-enriched Pudding Products on Glycemic and Satiety Response in Adults at Risk for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs, Natural Sciences and Engineering Research Council, Canada, Dairy Farmers of Ontario, Agriculture and Agri-Food Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Risk for Type 2 Diabetes Mellitus, Fibre, Postprandial Glucose, Postprandial Insulin, Postprandial Acetaminophen, Satiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tapioca Starch - Low-Fibre
Arm Type
Placebo Comparator
Arm Description
Tapoica starch pudding without added fibre
Arm Title
High Maltose Corn Syrup - Low-Fibre
Arm Type
Placebo Comparator
Arm Description
High maltose corn syrup pudding without added fibre
Arm Title
Trutol Glucose Beverage (#1)
Arm Type
Placebo Comparator
Arm Description
Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit.
Arm Title
Trutol Glucose Beverage (#2)
Arm Type
Placebo Comparator
Arm Description
Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit.
Arm Title
Yellow Mustard Gum Fibre - Tapioca Starch
Arm Type
Active Comparator
Arm Description
Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
Arm Title
Yellow Mustard Gum Fibre - High Maltose Corn Syrup
Arm Type
Active Comparator
Arm Description
Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
Arm Title
Soluble Flaxseed Gum Fibre - Tapioca Starch
Arm Type
Active Comparator
Arm Description
Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
Arm Title
Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup
Arm Type
Active Comparator
Arm Description
Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
Arm Title
Fenugreek Gum Fibre - Tapioca Starch
Arm Type
Active Comparator
Arm Description
Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
Arm Title
Fenugreek Gum Fibre - High Maltose Corn Syrup
Arm Type
Active Comparator
Arm Description
Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
Intervention Type
Other
Intervention Name(s)
Yellow Mustard Gum Fibre
Intervention Type
Other
Intervention Name(s)
Soluble Flaxseed Gum Fibre
Intervention Type
Other
Intervention Name(s)
Fenugreek Gum Fibre
Primary Outcome Measure Information:
Title
Fasting and postprandial blood glucose response for each pudding and control product
Description
Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Time Frame
Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Title
Fasting and postprandial insulin response for each pudding and control product
Description
Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Time Frame
Blood insulin will be analyzed for each each study visit (10 in total), at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Title
Fasting and postprandial acetaminophen absorption for each pudding and control product
Description
Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Time Frame
Blood acetaminophen will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Title
Satiety-producing effect for each pudding and control product
Description
Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed.
Time Frame
Satiety will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Secondary Outcome Measure Information:
Title
3-Day food records
Description
Participants will complete 3-day food records before the first treatment study visit to provide information about their background nutrient intake and dietary habits.
Time Frame
Over 3 days before the first treatment study visit
Other Pre-specified Outcome Measures:
Title
Fasted body weight
Description
Fasted body weight will be measured at each study before consuming the treatment product.
Time Frame
At each study treatment visit
Title
Heart rate and blood pressure
Description
Heart rate (beats per minute) and blood pressure (systolic/diastolic mmHg) will be measured at each study treatment visit before consuming the treatment product.
Time Frame
At each study treatment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison M Duncan, Ph.D., R.D.
Organizational Affiliation
University of Guelph, Human Nutraceutical Research Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda J Wright, Ph.D.
Organizational Affiliation
University of Guelph, Human Nutraceutical Research Unit
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alison M Duncan, Ph.D., R.D.
Organizational Affiliation
University of Guelph, Human Nutraceutical Research Unit
Official's Role
Study Director
Facility Information:
Facility Name
Human Nutraceutical Research Unit
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada

12. IPD Sharing Statement

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Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

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