Back to results

Millet Products Study - Investigation of Glycemic Index and Satiety

Primary Purpose

Hyperglycemia, Lack of Satiety

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Commercial white bread

Corn based products (porridge etc.)

Millet based products (porridge etc.)

About this trial

This is an interventional basic science trial for Hyperglycemia

Eligibility Criteria

19 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Human Nutraceutical Research Unit, University of Guelph

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Commercial white bread

Millet based products (porridge etc.)

Corn based products (porridge etc.)

Arm Description

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

Outcomes

Primary Outcome Measures

Determination of glycemic index based on collection of capillary plasma glucose

Secondary Outcome Measures

Self reported ratings of satiety

Full Information

NCT ID

NCT02075788

First Posted

February 26, 2014

Last Updated

January 21, 2016

Sponsor

University of Guelph

Collaborators

Bunge Global Innovation Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT02075788

Brief Title

Millet Products Study - Investigation of Glycemic Index and Satiety

Official Title

Millet Products Study - Investigation of Glycemic Index and Satiety

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Guelph

Collaborators

Bunge Global Innovation Incorporated

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia, Lack of Satiety

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Commercial white bread

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Millet based products (porridge etc.)

Arm Type

Experimental

Arm Description

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

Arm Title

Corn based products (porridge etc.)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Commercial white bread

Intervention Type

Other

Intervention Name(s)

Corn based products (porridge etc.)

Intervention Type

Other

Intervention Name(s)

Millet based products (porridge etc.)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Self reported ratings of satiety

Time Frame

Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Human Nutraceutical Research Unit, University of Guelph

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1G2W1

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Millet Products Study - Investigation of Glycemic Index and Satiety

We'll reach out to this number within 24 hrs