Millet Products Study - Investigation of Glycemic Index and Satiety

Hyperglycemia Clinical Trial

Official title:

Millet Products Study - Investigation of Glycemic Index and Satiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075788
• Other study ID #: 13AP004
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: January 21, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperglycemia
• Lack of Satiety

Intervention

Other:
• Commercial white bread

• Corn based products (porridge etc.)

• Millet based products (porridge etc.)

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit, University of Guelph	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Guelph	Bunge Global Innovation Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self reported ratings of satiety		Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours	No