Glucose and Insulin Responses to Test Foods

Not Applicable

Completed

• Conditions: Glucose Response; Insulin Response
• Interventions: Other: Reference Glucose; Other: Test Food 1 (Cereal); Other: Test Food 2 (Biscuit)

• Registration Number: NCT01671878
• Lead Sponsor: Mondelēz International, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-24
• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference Glucose	Reference Glucose	Glucose standard
Test Food 1	Test Food 1 (Cereal)	Cereal
Test Food 2	Test Food 2 (Biscuit)	Biscuit

Primary Outcome Measures

Name	Time	Method
Postprandial Glucose Response	3 hours

Secondary Outcome Measures

Name	Time	Method
Postprandial Insulin Response	3 hours

Trial Locations

Locations (1)

Glycemic Index Laboratories; 🇨🇦 Toronto, Ontario, Canada