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Completed

NCT Number: NCT02289612

Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yellow Mustard Gum Fibre

Other

Soluble Flaxseed Gum Fibre

Other

Fenugreek Gum Fibre

Other

Primary outcomes

  1. Fasting and postprandial blood glucose response for each pudding and control product

    Time frame: 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.

  2. Fasting and postprandial insulin response for each pudding and control product

    Time frame: 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.

  3. Fasting and postprandial acetaminophen absorption for each pudding and control product

    Time frame: 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.

  4. Satiety-producing effect for each pudding and control product

    Time frame: 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 outcomes

  1. 3-Day food records

    Time frame: 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 outcomes

  1. Fasted body weight

    Time frame: At each study treatment visit

    Fasted body weight will be measured at each study before consuming the treatment product.

  2. Heart rate and blood pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Agriculture and Agri-Food Canada
  • Dairy Farmers of Ontario
  • Natural Sciences and Engineering Research Council, Canada
  • Ontario Ministry of Agriculture, Food and Rural Affairs

Registry information

Official study 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

Acronym: Pudding

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2014
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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