Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

Type 2 Diabetes Mellitus Clinical Trial

— Pudding  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289612
• Other study ID #: 14AP003
• Secondary ID: 200603
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2018
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Yellow Mustard Gum Fibre

• Soluble Flaxseed Gum Fibre

• Fenugreek Gum Fibre

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
University of Guelph	Agriculture and Agri-Food Canada, Dairy Farmers of Ontario, Natural Sciences and Engineering Research Council, Canada, Ontario Ministry of Agriculture, Food and Rural Affairs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasted body weight	Fasted body weight will be measured at each study before consuming the treatment product.	At each study treatment visit
Other	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
Primary	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.
Primary	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.
Primary	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.
Primary	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	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