Glucose and Insulin Responses to Test Foods

This study has been completed.
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01671878
First received: August 21, 2012
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Glucose Response
Insulin Response
Other: Reference Glucose
Other: Test Food 1 (Cereal)
Other: Test Food 2 (Biscuit)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects

Resource links provided by NLM:


Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:
  • Postprandial Glucose Response [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial Insulin Response [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671878

Locations
Canada, Ontario
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
Mondelēz International, Inc.
Glycemic Index Laboratories, Inc
Investigators
Principal Investigator: Thomas Wolever, MD, PhD Glycemic Index Laboratories, Inc
  More Information

No publications provided

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01671878     History of Changes
Other Study ID Numbers: GIl1244
Study First Received: August 21, 2012
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014