Clinical trial NCT02075788: Millet Products Study - Investigation of Glycemic Index and Satiety
Official title: Millet Products Study - Investigation of Glycemic Index and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Lack of Satiety
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Bunge Global Innovation Incorporated
First posted: 2014-03-03
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Determination of glycemic index based on collection of capillary plasma glucose
timeFrame: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
Secondary outcomes:
measure: Self reported ratings of satiety
timeFrame: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit, University of Guelph
state: Ontario
Study officials:
References: