- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03493022
Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola
April 9, 2018 updated by: PepsiCo Global R&D
The objectives of this study are to examine the blood glucose and serum insulin response elicited by servings of Test Granola and Control Granola containing equal amounts of available carbohydrate over a 3 h time period.
In addition, the subjective hunger response to these foods will be measured over 3 h.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Toronto, Canada
- Glycemic Index Laboratories
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant, non-lactating females, 18-65 years of age, inclusive
- Body mass index (BMI) between 21.0 and 32.0 kg/m², inclusive, at screening (visit 1).
- No participation in a PepsiCo study at GI Labs for at least 6 months from signing the consent form or previously enrolled into a PepsiCo Granola RAG:SAG trial (PEP-1701, PEP-1711, PEP-1712).
- No participation in any clinical trial for at least 30 days from signing the consent form.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
- Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
- Fasting serum glucose <7.0mmol/L or capillary whole blood glucose <6.3mmol/L.
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
- Failure to meet any one of the inclusion criteria
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, 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.
- Major trauma or major surgical event within 6 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Lactose intolerance.
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
- Change in body weight of >3.5kg within 4 weeks of the screening visit.
- Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Exposure to any investigational drug product within 30 d prior to screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Test Granola
50.5 g Test Granola
|
50.5 Test Granola
|
PLACEBO_COMPARATOR: Control Granola
54.3 Control Granola
|
54.3 Control Granola
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incremental area under the blood glucose curve
Time Frame: 0-2 hours
|
0-2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incremental areas under the curve of blood glucose
Time Frame: 0-3 and 2-3 hours
|
0-3 and 2-3 hours
|
incremental areas under the curve of serum insulin
Time Frame: 0-2 hours, 2-3 hours, 0-3 hours
|
0-2 hours, 2-3 hours, 0-3 hours
|
subjective hunger response
Time Frame: 0-3 hours
|
0-3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 25, 2017
Primary Completion (ACTUAL)
December 15, 2017
Study Completion (ACTUAL)
December 15, 2017
Study Registration Dates
First Submitted
March 31, 2018
First Submitted That Met QC Criteria
April 9, 2018
First Posted (ACTUAL)
April 10, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 9, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PEP-1710
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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