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

A Randomized, Controlled, Double-Blind Crossover Trial to Assess 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.

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Oatmeal

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• 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 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oatmeal 1; 40 g cereal	Other: Oatmeal
Experimental: Oatmeal2; 40 g cereal	Other: Oatmeal
Experimental: Oatmeal 3; 40 g cereal	Other: Oatmeal
Placebo Comparator: Ready to eat cereal; 32.2 g cereal	Other: Oatmeal
Placebo Comparator: Hot cereal; 28.8 g cereal	Other: Oatmeal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
peak rise of blood glucose	3 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Incremental area under the blood glucose and insulin response curves	0-3 hours post dose
Peak rise of insulin	0-3 hours post dose
Peak glucose and insulin concentrations	0-3 hours post dose
Blood glucose and insulin concentrations at each time point over a 3hr period	0-3 hours post dose

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1519