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OpenTrials
Completed

NCT Number: NCT03165773

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories

Toronto, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oatmeal

Other

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

Corn grits

Other

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

Primary outcomes

  1. Exogenous glucose 0-4 h

    Time frame: 0-4 hours post consumption

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 24, 2017
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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