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OpenTrials
Completed

NCT Number: NCT01671878

Glucose and Insulin Responses to Test Foods

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reference Glucose

Other

Test Food 1 (Cereal)

Other

Test Food 2 (Biscuit)

Other

Primary outcomes

  1. Postprandial Glucose Response

    Time frame: 3 hours

Secondary outcomes

  1. Postprandial Insulin Response

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Mondelēz International, Inc.

Industry

Collaborators

  • Glycemic Index Laboratories, Inc

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2012
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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