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Completed

NCT Number: NCT02075788

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.

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Key information

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercial white bread

Other

Corn based products (porridge etc.)

Other

Millet based products (porridge etc.)

Other

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

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Bunge Global Innovation Incorporated

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 3, 2014
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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