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Millet Products Study - Investigation of Glycemic Index and Satiety

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ClinicalTrials.gov Identifier: NCT02075788
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : January 22, 2016
Sponsor:
Collaborator:
Bunge Global Innovation Incorporated
Information provided by (Responsible Party):
Amanda Wright, Ph.D., University of Guelph

Brief Summary:
The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.

Condition or disease Intervention/treatment Phase
Hyperglycemia Lack of Satiety Other: Commercial white bread Other: Corn based products (porridge etc.) Other: Millet based products (porridge etc.) Not Applicable

Detailed Description:

The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.

This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.

All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Millet Products Study - Investigation of Glycemic Index and Satiety
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Placebo Comparator: Commercial white bread
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
Other: Commercial white bread
Experimental: Millet based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
Other: Millet based products (porridge etc.)
Active Comparator: Corn based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
Other: Corn based products (porridge etc.)



Primary Outcome Measures :
  1. Determination of glycemic index based on collection of capillary plasma glucose [ Time Frame: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes ]

Secondary Outcome Measures :
  1. Self reported ratings of satiety [ Time Frame: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men, age 19-40, non-smoking
  • Normal fasting plasma glucose (<5.6 mmol/L but not below 3.6 mmol/L)
  • Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. <7.8 mmol/L but not below 3.6 mmol/L)
  • BMI ranging from 18.5 to 29.9 kg/m2

Exclusion Criteria:

  • Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
  • Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
  • Smoking or use of recreational drugs
  • Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
  • Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
  • Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
  • Food neophobic defined by Food Neophobia Scale questionnaire
  • Unusual sleep patterns or irregular breakfast consumption
  • Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
  • Food allergies or any life-threatening allergy (food or otherwise)
  • Inflammatory bowel disease or other gastrointestinal disorders
  • Use of drugs which influence carbohydrate metabolism
  • Training or elite athletes
  • Inability to adhere to Study Protocols

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): NCT02075788


Locations
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Canada, Ontario
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, Canada, N1G2W1
Sponsors and Collaborators
University of Guelph
Bunge Global Innovation Incorporated
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Responsible Party: Amanda Wright, Ph.D., Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT02075788    
Other Study ID Numbers: 13AP004
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases