Glucose and Insulin Responses to Test Foods

NCT ID: NCT01671878

Last Updated: 2013-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Glucose Response Insulin Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Reference Glucose

Glucose standard

Group Type OTHER

Reference Glucose

Intervention Type OTHER

Test Food 1

Cereal

Group Type EXPERIMENTAL

Test Food 1 (Cereal)

Intervention Type OTHER

Test Food 2

Biscuit

Group Type EXPERIMENTAL

Test Food 2 (Biscuit)

Intervention Type OTHER

Interventions

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Reference Glucose

Intervention Type OTHER

Test Food 1 (Cereal)

Intervention Type OTHER

Test Food 2 (Biscuit)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Locations

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Glycemic Index Laboratories

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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GIl1244

Identifier Type: -

Identifier Source: org_study_id

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