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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014