- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818452
Glycemic Impact of Oatmeal Plus OatWellXF28
December 5, 2016 updated by: PepsiCo Global R&D
Affecting the Glycemic Impact of Quaker Instant Oatmeal by Adding OatWell28XF: a Dose-Response Study
The objective of this study is to determine the effect on glycemic responses of adding various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least 20% less than that elicited by a β-glucan-free cereal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toronto, Canada
- GI Labs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
- Change in body weight of >3.5kg within 4 weeks of the screening visit.
- Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Exposure to any non-registered drug product within 30 d prior to screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oatmeal containing beta-glucan
27 g oatmeal
|
|
Experimental: Oatmeal containing beta-glucan + OatWell28XF Intervention 1
27.72g oatmeal
|
Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
|
Experimental: Oatmeal containing beta-glucan + OatWell28XF Intervention 2
28.43g oatmeal
|
Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
|
Experimental: Oatmeal containing beta-glucan + OatWell28XF Intervention 3
29.86g oatmeal
|
Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
|
Experimental: Oatmeal containing beta-glucan + OatWell28XF Intervention 4
32.72g oatmeal
|
Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
|
Placebo Comparator: Hot Cereal - Cream of Rice
20g oatmeal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose incremental area under the blood glucose response curve
Time Frame: 2 hours post consumption
|
2 hours post consumption
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak rise of blood glucose
Time Frame: 2 hours post consumption
|
2 hours post consumption
|
Glucose concentrations and increments
Time Frame: 2 hours post consumption
|
2 hours post consumption
|
Peak glucose concentration
Time Frame: 2 hours post consumption
|
2 hours post consumption
|
Rate of decline of glucose
Time Frame: 2 hours post consumption
|
2 hours post consumption
|
Time to return to baseline
Time Frame: 2 hours post consumption
|
2 hours post consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
June 14, 2016
First Submitted That Met QC Criteria
June 27, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Estimate)
December 7, 2016
Last Update Submitted That Met QC Criteria
December 5, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- PEP-1523
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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