NCT02616159

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

November 24, 2015

Last Update Submit

June 20, 2016

Conditions

Glycemic Response

Outcome Measures

Primary Outcomes (1)

  • peak rise of blood glucose

    3 hours post dose

Secondary Outcomes (4)

  • 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

Study Arms (5)

Oatmeal 1

EXPERIMENTAL

40 g cereal

Other: Oatmeal

Oatmeal2

EXPERIMENTAL

40 g cereal

Other: Oatmeal

Oatmeal 3

EXPERIMENTAL

40 g cereal

Other: Oatmeal

Ready to eat cereal

PLACEBO COMPARATOR

32.2 g cereal

Other: Oatmeal

Hot cereal

PLACEBO COMPARATOR

28.8 g cereal

Other: Oatmeal

Interventions

OatmealOTHER
Hot cerealOatmeal 1Oatmeal 3Oatmeal2Ready to eat cereal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories

Toronto, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 26, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 21, 2016

Record last verified: 2015-11

Locations

CA(1)