Clinical trial NCT02289612: Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products
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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Risk for Type 2 Diabetes Mellitus
Fibre
Postprandial Glucose
Postprandial Insulin
Postprandial Acetaminophen
Satiety
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Agriculture, Food and Rural Affairs
name: Natural Sciences and Engineering Research Council, Canada
name: Dairy Farmers of Ontario
name: Agriculture and Agri-Food Canada
First posted: 2014-11-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Fasting and postprandial blood glucose response for each pudding and control product
timeFrame: 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.
measure: Fasting and postprandial insulin response for each pudding and control product
timeFrame: 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.
measure: Fasting and postprandial acetaminophen absorption for each pudding and control product
timeFrame: 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.
measure: Satiety-producing effect for each pudding and control product
timeFrame: 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 outcomes:
measure: 3-Day food records
timeFrame: Over 3 days before the first treatment study visit
Other outcomes:
measure: Fasted body weight
timeFrame: At each study treatment visit
measure: Heart rate and blood pressure
timeFrame: At each study treatment visit
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
Study officials:
affiliation: University of Guelph, Human Nutraceutical Research Unit
name: Alison M Duncan, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Guelph, Human Nutraceutical Research Unit
name: Amanda J Wright, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Guelph, Human Nutraceutical Research Unit
name: Alison M Duncan, Ph.D., R.D.
role: STUDY_DIRECTOR
References: