Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
| Registry | NCT01671878 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none |
| Enrollment | 12 (Actual) |
| Sponsor | Mondelēz International, Inc. (Industry); collaborators: Glycemic Index Laboratories, Inc |
| Conditions | Glucose Response, Insulin Response |
| Interventions | Reference Glucose, Test Food 1 (Cereal), Test Food 2 (Biscuit) (Other) |
| Dates | start 2012-09-01, primary completion 2012-11-01, completion 2012-11-01, first posted 2012-08-24, last updated 2013-05-07 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Glucose Response All trials for Insulin Response All trials of Reference Glucose All trials of Test Food 1 (Cereal)
In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Reference Glucose | Other | Other: Reference Glucose | Glucose standard |
| Test Food 1 | Experimental | Other: Test Food 1 (Cereal) | Cereal |
| Test Food 2 | Experimental | Other: Test Food 2 (Biscuit) | Biscuit |
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Glycemic Index Laboratories | Toronto, Ontario | Canada |