Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

Study Overview
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Yellow Mustard Gum Fibre
* Other: Soluble Flaxseed Gum Fibre
* Other: Fenugreek Gum Fibre


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk for Type 2 Diabetes Mellitus, Fibre, Postprandial Glucose, Postprandial Insulin, Postprandial Acetaminophen, Satiety