Clinical trial NCT03165773: Four-hour Glycemic Kinetic Response Following 13C-enriched Oatmeal Breakfast Compared to Hot Corn Grits
Official title: Four-hour Glycemic Kinetic Response Following 13C-enriched Oatmeal Breakfast Compared to Hot Corn Grits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic and Insulinemic Response
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2017-05-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of this study are to assess the 4 hr postprandial kinetics of total and exogenous glucose in response to consumption of oatmeal containing a high percentage of the viscous agent β-glucan, in comparison to a β-glucan free corn cereal that is matched by grams of available carbohydrate.


Eligibility criteria: Inclusion Criteria:

* Subject is 18-45 years of age.
* Subject has a body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive at screening (visit 1).
* Subject has normal fasting serum glucose (\<6.5 mmol/L capillary corresponding to whole blood glucose \<5.8 mmol/L) at beginning of each visit.
* Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria.
* Failure to comply with pre-visit instructions on diet and physical activity.
* Known history of clinically important medical conditions, such as any major trauma or surgical event within 3 months of screening, AIDS, cancer, hepatitis, endocrine (including Type 1 and 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.
* Subject using medications or supplements known to influence carbohydrate or lipid metabolism, including, but not limited to adrenergic blocks, diuretics, thiazolidinediones, metformin, statins, and systemic corticosteroids within 4 weeks of the screening visit.
* Subject who cannot or will not comply with the experimental procedures or does not follow GI Labs safety guidelines.
* Subject has a known intolerance, sensitivity or allergy to any ingredients in the study products.
* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Primary outcomes:
measure: Exogenous glucose 0-4 h
timeFrame: 0-4 hours post consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories
Study officials:
affiliation: GI Labs
name: Thomas Wolever, MD
role: PRINCIPAL_INVESTIGATOR
References: