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Glucose and Insulin Responses to Test Foods

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01671878
Enrollment
12
Registered
2012-08-24
Start date
2012-09-30
Completion date
2012-11-30
Last updated
2013-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Response, Insulin Response

Brief summary

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

Interventions

OTHERTest Food 1 (Cereal)
OTHERTest Food 2 (Biscuit)

Sponsors

Glycemic Index Laboratories, Inc
CollaboratorINDUSTRY
Mondelēz International, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Postprandial Glucose Response3 hours

Secondary

MeasureTime frame
Postprandial Insulin Response3 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026