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

NCT03165773 | Completed

• 1 other identifier: PEP-1503
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Exogenous glucose 0-4 h

  0-4 hours post consumption

Study Arms (2)

Oatmeal

EXPERIMENTAL

87 grams oatmeal

Other: Oatmeal

Corn grits

ACTIVE COMPARATOR

67 grams corn grits

Other: Corn grits

Interventions

Oatmeal OTHER

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

Oatmeal

Corn grits OTHER

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

Corn grits

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Glycemic Index Laboratories

Toronto, Canada

Location

Study Officials

• Thomas Wolever, MD

  GI Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 24, 2017
• Study Start: August 24, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)