Millet Products Study - Investigation of Glycemic Index and Satiety

Study Overview
=================
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.

Official Title
-----------------
Millet Products Study - Investigation of Glycemic Index and Satiety

Conditions
-----------------
Hyperglycemia, Lack of Satiety

Intervention / Treatment
-----------------
* Other: Commercial white bread
* Other: Corn based products (porridge etc.)
* Other: Millet based products (porridge etc.)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of glycemic index based on collection of capillary plasma glucose |  | Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported ratings of satiety |  | Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours |