Millet Products Study - Investigation of Glycemic Index and Satiety

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.)

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Canada, Ontario

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, Canada, N1G2W1

Sponsors and Collaborators

University of Guelph

Bunge Global Innovation Incorporated

More Information

• 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
• Last Update Posted: January 22, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases