Millet Products Study - Investigation of Glycemic Index and Satiety

NCT ID: NCT02075788

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

Brief Summary

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

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.

Conditions

Hyperglycemia; Lack of Satiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Commercial white bread

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

Group Type: PLACEBO_COMPARATOR

Commercial white bread

Intervention Type: OTHER

Millet based products (porridge etc.)

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

Group Type: EXPERIMENTAL

Millet based products (porridge etc.)

Intervention Type: OTHER

Corn based products (porridge etc.)

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

Group Type: ACTIVE_COMPARATOR

Corn based products (porridge etc.)

Intervention Type: OTHER

Interventions

Commercial white bread

Intervention Type: OTHER

Corn based products (porridge etc.)

Intervention Type: OTHER

Millet based products (porridge etc.)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bunge Global Innovation Incorporated

UNKNOWN

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

Amanda Wright, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, Canada

Countries

Canada

Other Identifiers

13AP004

Identifier Type: -

Identifier Source: org_study_id