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Glycemic and Insulinemic Impact of a Test Granola Versus a Control Granola

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495778
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glycemic Insulinemic Subjective Hunger Responses Other: Test Granola Other: Control Granola Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Glycemic and Insulinemic Impact of a Test Granola Versus a Control Granola
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Arm Intervention/treatment
Experimental: Test Granola
50.5 g Test Granola
Other: Test Granola
50.5 Test Granola

Placebo Comparator: Control Granola
54.3 Control Granola
Other: Control Granola
54.3 Control Granola




Primary Outcome Measures :
  1. Incremental area under the blood glucose curve from 0-2 h elicited by a serving of Test Granola and Control Granola [ Time Frame: 0-2 hours post consumption ]

Secondary Outcome Measures :
  1. Incremental areas under the curve of blood glucose [ Time Frame: 0-3 hours ]
  2. Incremental areas under the curve of blood glucose [ Time Frame: 2-3 hours ]
  3. Incremental areas under the curve of serum insulin [ Time Frame: 0-2 hours, 0-3 hours and 2-3 hours ]
  4. Subjective hunger using questionnaire [ Time Frame: 0-2 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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 surgical event within 3 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.

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): NCT03495778


Locations
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Canada
Glycemic Index Laboratories
Toronto, Canada
Sponsors and Collaborators
PepsiCo Global R&D
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03495778    
Other Study ID Numbers: PEP-1701
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No