Glucose and Insulin Responses to Test Foods

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

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

Study Overview

• Status: Completed
• Conditions: Glucose Response; Insulin Response
• Intervention / Treatment: Other: Reference Glucose; Other: Test Food 1 (Cereal); Other: Test Food 2 (Biscuit)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic Index Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reference Glucose; Glucose standard	Other: Reference Glucose
Experimental: Test Food 1; Cereal	Other: Test Food 1 (Cereal)
Experimental: Test Food 2; Biscuit	Other: Test Food 2 (Biscuit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postprandial Glucose Response	3 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Postprandial Insulin Response	3 hours

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: Glycemic Index Laboratories, Inc

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: GIl1244