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Glucose and Insulin Responses to Test Foods

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ClinicalTrials.gov Identifier: NCT01671878
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glucose Response Insulin Response Other: Reference Glucose Other: Test Food 1 (Cereal) Other: Test Food 2 (Biscuit) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Postprandial Glucose Response [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Postprandial Insulin Response [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01671878     History of Changes
Other Study ID Numbers: GIl1244
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013