Millet Products Study - Investigation of Glycemic Index and Satiety

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

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Lack of Satiety
• Intervention / Treatment: Other: Commercial white bread; Other: Millet based products (porridge etc.); Other: Corn based products (porridge etc.)

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G2W1
      • Human Nutraceutical Research Unit, University of Guelph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Guelph
• Collaborators: Bunge Global Innovation Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 13AP004