Type 2 Diabetes Mellitus
Conditions
Keywords
Risk for Type 2 Diabetes Mellitus, Fibre, Postprandial Glucose, Postprandial Insulin, Postprandial Acetaminophen, Satiety
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.
Interventions
OTHERYellow Mustard Gum Fibre
OTHERSoluble Flaxseed Gum Fibre
OTHERFenugreek Gum Fibre
Sponsors
Ontario Ministry of Agriculture, Food and Rural Affairs
Natural Sciences and Engineering Research Council, Canada
Dairy Farmers of Ontario
Agriculture and Agri-Food Canada
University of Guelph
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting and postprandial blood glucose response for each pudding and control product | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 3-Day food records | Over 3 days before the first treatment study visit | Participants will complete 3-day food records before the first treatment study visit to provide information about their background nutrient intake and dietary habits. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart rate and blood pressure | At each study treatment visit | Heart rate (beats per minute) and blood pressure (systolic/diastolic mmHg) will be measured at each study treatment visit before consuming the treatment product. |
| Fasted body weight | At each study treatment visit | Fasted body weight will be measured at each study before consuming the treatment product. |
Countries
Canada
Outcome results
None listed