Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

University of Guelph

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Fenugreek Gum Fibre; Other: Soluble Flaxseed Gum Fibre; Other: Yellow Mustard Gum Fibre

Study type: Interventional

Funder types: Other

Identifiers

NCT02289612

200603

14AP003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 10 patient groups, including a placebo group

Tapioca Starch - Low-Fibre

Placebo Comparator group

Description:

Tapoica starch pudding without added fibre

Treatment:

Other: Yellow Mustard Gum Fibre

High Maltose Corn Syrup - Low-Fibre

Placebo Comparator group

Description:

High maltose corn syrup pudding without added fibre

Treatment:

Other: Yellow Mustard Gum Fibre

Trutol Glucose Beverage (#1)

Placebo Comparator group

Description:

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

Treatment:

Other: Yellow Mustard Gum Fibre

Trutol Glucose Beverage (#2)

Placebo Comparator group

Description:

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

Treatment:

Other: Yellow Mustard Gum Fibre

Yellow Mustard Gum Fibre - Tapioca Starch

Active Comparator group

Description:

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

Treatment:

Other: Yellow Mustard Gum Fibre

Yellow Mustard Gum Fibre - High Maltose Corn Syrup

Active Comparator group

Description:

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

Treatment:

Other: Yellow Mustard Gum Fibre

Soluble Flaxseed Gum Fibre - Tapioca Starch

Active Comparator group

Description:

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

Treatment:

Other: Soluble Flaxseed Gum Fibre

Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup

Active Comparator group

Description:

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

Treatment:

Other: Soluble Flaxseed Gum Fibre

Fenugreek Gum Fibre - Tapioca Starch

Active Comparator group

Description:

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

Treatment:

Other: Fenugreek Gum Fibre

Fenugreek Gum Fibre - High Maltose Corn Syrup

Active Comparator group

Description:

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

Treatment:

Other: Fenugreek Gum Fibre