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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Yellow Mustard Gum Fibre; Other: Soluble Flaxseed Gum Fibre; Other: Fenugreek Gum Fibre

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 2W1
      • Human Nutraceutical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Tapioca Starch - Low-Fibre; Tapoica starch pudding without added fibre	Other: Yellow Mustard Gum Fibre
PLACEBO_COMPARATOR: High Maltose Corn Syrup - Low-Fibre; High maltose corn syrup pudding without added fibre	Other: Yellow Mustard Gum Fibre
PLACEBO_COMPARATOR: Trutol Glucose Beverage (#1); Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit.	Other: Yellow Mustard Gum Fibre
PLACEBO_COMPARATOR: Trutol Glucose Beverage (#2); Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit.	Other: Yellow Mustard Gum Fibre
ACTIVE_COMPARATOR: Yellow Mustard Gum Fibre - Tapioca Starch; Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.	Other: Yellow Mustard Gum Fibre
ACTIVE_COMPARATOR: Yellow Mustard Gum Fibre - High Maltose Corn Syrup; Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.	Other: Yellow Mustard Gum Fibre
ACTIVE_COMPARATOR: Soluble Flaxseed Gum Fibre - Tapioca Starch; Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.	Other: Soluble Flaxseed Gum Fibre
ACTIVE_COMPARATOR: Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup; Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.	Other: Soluble Flaxseed Gum Fibre
ACTIVE_COMPARATOR: Fenugreek Gum Fibre - Tapioca Starch; Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.	Other: Fenugreek Gum Fibre
ACTIVE_COMPARATOR: Fenugreek Gum Fibre - High Maltose Corn Syrup; Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.	Other: Fenugreek Gum Fibre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
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.	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.
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	Over 3 days before the first treatment study visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasted body weight	Fasted body weight will be measured at each study before consuming the treatment product.	At each study treatment visit
Heart rate and blood pressure	Heart rate (beats per minute) and blood pressure (systolic/diastolic mmHg) will be measured at each study treatment visit before consuming the treatment product.	At each study treatment visit

Collaborators and Investigators

• Sponsor: University of Guelph
• Collaborators: Agriculture and Agri-Food Canada; Natural Sciences and Engineering Research Council, Canada; Ontario Ministry of Agriculture, Food and Rural Affairs; Dairy Farmers of Ontario
• Investigators: Principal Investigator: Alison M Duncan, Ph.D., R.D., University of Guelph, Human Nutraceutical Research Unit; Study Director: Amanda J Wright, Ph.D., University of Guelph, Human Nutraceutical Research Unit; Study Director: Alison M Duncan, Ph.D., R.D., University of Guelph, Human Nutraceutical Research Unit

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 9, 2014
• First Posted (ESTIMATE): November 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Satiety; Fibre; Postprandial Glucose; Risk for Type 2 Diabetes Mellitus; Postprandial Insulin; Postprandial Acetaminophen
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 14AP003; 200603 (OTHER_GRANT: OMAFRA)