Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03493022
• Date of registration: 31/03/2018
• Prospective Registration: No
• Primary sponsor: PepsiCo Global R&D
• Public title: Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola
• Scientific title: Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola
• Date of first enrolment: August 25, 2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03493022
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Glycemic Response

Insulinemic Response

Subject Hunger Response

Intervention(s)

Other: Test Granola

Other: Control Granola

Primary Outcome(s)

Incremental area under the blood glucose curve [Time Frame: 0-2 hours]

Secondary Outcome(s)

incremental areas under the curve of serum insulin [Time Frame: 0-2 hours, 2-3 hours, 0-3 hours]

subjective hunger response [Time Frame: 0-3 hours]

incremental areas under the curve of blood glucose [Time Frame: 0-3 and 2-3 hours]

Secondary ID(s)

PEP-1710

Source(s) of Monetary Support

Please refer to primary and secondary sponsors