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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03165773
Enrollment
15
Registered
2017-05-24
Start date
2015-08-24
Completion date
2016-08-31
Last updated
2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic and Insulinemic Response

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.

Interventions

OTHEROatmeal

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

OTHERCorn grits

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

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Exogenous glucose 0-4 h0-4 hours post consumption

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026