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Trial record 15 of 23 for:    fenugreek

Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products (Pudding)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02289612
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Ontario Ministry of Agriculture, Food and Rural Affairs
Natural Sciences and Engineering Research Council, Canada
Dairy Farmers of Ontario
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Alison Duncan, University of Guelph

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Yellow Mustard Gum Fibre Other: Soluble Flaxseed Gum Fibre Other: Fenugreek Gum Fibre Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : November 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Fenugreek

Arm Intervention/treatment
Placebo Comparator: Tapioca Starch - Low-Fibre
Tapoica starch pudding without added fibre
Other: Yellow Mustard Gum Fibre
Placebo Comparator: High Maltose Corn Syrup - Low-Fibre
High maltose corn syrup pudding without added fibre
Other: Yellow Mustard Gum Fibre
Placebo Comparator: Trutol Glucose Beverage (#1)
Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit.
Other: Yellow Mustard Gum Fibre
Placebo Comparator: Trutol Glucose Beverage (#2)
Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit.
Other: Yellow Mustard Gum Fibre
Active Comparator: Yellow Mustard Gum Fibre - Tapioca Starch
Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
Other: Yellow Mustard Gum Fibre
Active Comparator: Yellow Mustard Gum Fibre - High Maltose Corn Syrup
Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
Other: Yellow Mustard Gum Fibre
Active Comparator: Soluble Flaxseed Gum Fibre - Tapioca Starch
Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
Other: Soluble Flaxseed Gum Fibre
Active Comparator: Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup
Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
Other: Soluble Flaxseed Gum Fibre
Active Comparator: Fenugreek Gum Fibre - Tapioca Starch
Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
Other: Fenugreek Gum Fibre
Active Comparator: Fenugreek Gum Fibre - High Maltose Corn Syrup
Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
Other: Fenugreek Gum Fibre



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289612


Locations
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Canada, Ontario
Human Nutraceutical Research Unit
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Ontario Ministry of Agriculture, Food and Rural Affairs
Natural Sciences and Engineering Research Council, Canada
Dairy Farmers of Ontario
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Alison M Duncan, Ph.D., R.D. University of Guelph, Human Nutraceutical Research Unit
Study Director: Amanda J Wright, Ph.D. University of Guelph, Human Nutraceutical Research Unit
Study Director: Alison M Duncan, Ph.D., R.D. University of Guelph, Human Nutraceutical Research Unit

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Responsible Party: Alison Duncan, Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT02289612     History of Changes
Other Study ID Numbers: 14AP003
200603 ( Other Grant/Funding Number: OMAFRA )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Alison Duncan, University of Guelph:
Risk for Type 2 Diabetes Mellitus
Fibre
Postprandial Glucose
Postprandial Insulin
Postprandial Acetaminophen
Satiety
Additional relevant MeSH terms:
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Fenugreek seed meal
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mechlorethamine
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Hypoglycemic Agents
Physiological Effects of Drugs