Glucose and Insulin Responses to Test Foods

Glucose Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671878
• Other study ID #: GIl1244
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: May 6, 2013
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glucose Response
• Insulin Response

Intervention

Other:
• Reference Glucose

• Test Food 1 (Cereal)

• Test Food 2 (Biscuit)

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	Glycemic Index Laboratories, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Glucose Response		3 hours	No
Secondary	Postprandial Insulin Response		3 hours	No