Glucose and Insulin Responses to Test Foods

Study Overview
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Brief Summary
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In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.

Official Title
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Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects

Conditions
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Glucose Response, Insulin Response

Intervention / Treatment
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* Other: Reference Glucose
* Other: Test Food 1 (Cereal)
* Other: Test Food 2 (Biscuit)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male & half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include: Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose < 5.6 mmol/L (100 mg/dL) AND plasma glucose levels < 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit) Systolic blood pressure 100-150 mmHg inclusive Diastolic blood pressure 60-90 mmHg inclusive Resting heart rate 50-90 beats/min inclusive after 3 minute rest Able to refrain from eating legumes and drinking alcohol the day before each test session Fasting triglycerides < 2.0 mmol/L (178 mg/dL) Fasting HDL cholesterol > 0.9 mmol/L (35 mg/dL) for males and > 1.1mmol/L (42 mg/dL) for females Fasting LDL cholesterol < 5.0 mmol/L (193 mg/dL) AST and ALT < 120% of upper limit of normal (ULN) hsCRP < 10 mg/L Urea and creatinine < 150% ULN Exclusion Criteria: failure to meet any one of the inclusion criteria age less than 18 or over 45 years known history or AIDS, hepatitis, diabetes or a heart condition participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines. Food allergies of any kind General anaesthesia in the month prior to inclusion. Smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reference Glucose<br>Glucose standard | Other: Reference Glucose<br> <br> |
| Experimental: Test Food 1<br>Cereal | Other: Test Food 1 (Cereal)<br> <br> |
| Experimental: Test Food 2<br>Biscuit | Other: Test Food 2 (Biscuit)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glucose Response |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Insulin Response |  | 3 hours |