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

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.

Study Overview

• Status: Completed
• Conditions: Glycemic and Insulinemic Response
• Intervention / Treatment: Other: Oatmeal; Other: Corn grits

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • Glycemic Index Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oatmeal; 87 grams oatmeal	Other: Oatmeal; Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
Active Comparator: Corn grits; 67 grams corn grits	Other: Corn grits; Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exogenous glucose 0-4 h	0-4 hours post consumption

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Thomas Wolever, MD, GI Labs

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1503

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