Millet Products Study - Investigation of Glycemic Index and Satiety (NCT02075788) | Clinical Trial Compass
CompletedNot Applicable
Millet Products Study - Investigation of Glycemic Index and Satiety
Canada12 participantsStarted 2014-01
Plain-language summary
The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.
Who can participate
Age range
19 Years – 40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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