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Completed

NCT Number: NCT02616159

Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals

The objectives of this study are to compare the glycemic and insulinemic responses over 3 hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat and hot cereals.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories

Toronto, Canada

About this study

Participant eligibility will be screened at visit 1. The study will be a randomized, cross-over design. Participants will come to the study site on 5 separate occasions separated by a 2-day to 2-week washout period. Participants will arrive to the lab in a fasted state. 2 fasting blood samples will be collected, and further blood sampled will be taken over a 3-hour period post study product consumption.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or non-pregnant females, 18-75 years of age, inclusive
  • Body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
  • Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
  • Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
  • Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
  • Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
  • Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
  • Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion criteria

  • Failure to meet any one of the inclusion criteria
  • Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or 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.
  • Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
  • Major trauma or surgical event within 3 months of screening.
  • Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
  • Known intolerance, sensitivity or allergy to any ingredients in the study products.
  • Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).

Treatment and study plan

Oatmeal

Other

Primary outcomes

  1. peak rise of blood glucose

    Time frame: 3 hours post dose

Secondary outcomes

  1. Incremental area under the blood glucose and insulin response curves

    Time frame: 0-3 hours post dose

  2. Peak rise of insulin

    Time frame: 0-3 hours post dose

  3. Peak glucose and insulin concentrations

    Time frame: 0-3 hours post dose

  4. Blood glucose and insulin concentrations at each time point over a 3hr period

    Time frame: 0-3 hours post dose

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

A Randomized, Controlled, Double-Blind Crossover Trial to Assess Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2015
Registry last updated
Jun 21, 2016

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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