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CompletedNCT02075788Updated Jan 22, 2016

Millet Products Study - Investigation of Glycemic Index and Satiety

An interventional study of Commercial white bread and Corn based products (porridge etc.) in Hyperglycemia and Lack of Satiety, sponsored by University of Guelph. Completed at 1 site in Canada. Open to male participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-22.

Sponsored by University of Guelph · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hyperglycemia
  • Lack of Satiety

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03

In context

Hyperglycemia

713 studies on the registry are indexed under Hyperglycemia; 108 are open to participants now.

This study's enrollment of 12 is below the median of 45 across 531 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

University of Guelph is the lead sponsor of 70 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • 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.)

Interventions

  • OtherCommercial white bread
  • OtherCorn based products (porridge etc.)
  • OtherMillet based products (porridge etc.)
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Self reported ratings of satiety

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

07

Study locations

1 site
  • Human Nutraceutical Research Unit, University of Guelph
    Guelph, Ontario N1G2W1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02075788
Lead sponsor
University of Guelph
Collaborators
Bunge Global Innovation Incorporated
Responsible party
Amanda Wright, Ph.D. (Associate Professor, University of Guelph) — Principal investigator
First posted
Mar 3, 2014
Start date
Jan 2014
Primary completion
Sep 2014
Completion
Jun 2015
Last update
Jan 22, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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