Four-hour Glycemic Kinetic Response Following 13C-enriched Oatmeal Breakfast Compared to Hot Corn Grits

NCT ID: NCT03165773

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-24
• Study Completion Date: 2016-08-31

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.

Conditions

Glycemic and Insulinemic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Oatmeal

87 grams oatmeal

Group Type: EXPERIMENTAL

Oatmeal

Intervention Type: OTHER

Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence

Corn grits

67 grams corn grits

Group Type: ACTIVE_COMPARATOR

Corn grits

Intervention Type: OTHER

Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence

Interventions

Oatmeal

Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence

Intervention Type: OTHER

Corn grits

Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence

Intervention Type: OTHER

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Wolever, MD

Role: PRINCIPAL_INVESTIGATOR

GI Labs

Locations

Glycemic Index Laboratories

Toronto, , Canada

Countries

Canada

Other Identifiers

PEP-1503

Identifier Type: -

Identifier Source: org_study_id