Clinical trial NCT02818452: Glycemic Impact of Oatmeal Plus OatWellXF28
Official title: Affecting the Glycemic Impact of Quaker Instant Oatmeal by Adding OatWell28XF: a Dose-Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Responses
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2016-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glucose incremental area under the blood glucose response curve
timeFrame: 2 hours post consumption
Secondary outcomes:
measure: Peak rise of blood glucose
timeFrame: 2 hours post consumption
measure: Glucose concentrations and increments
timeFrame: 2 hours post consumption
measure: Peak glucose concentration
timeFrame: 2 hours post consumption
measure: Rate of decline of glucose
timeFrame: 2 hours post consumption
measure: Time to return to baseline
timeFrame: 2 hours post consumption
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: GI Labs
Study officials:
affiliation: GI Laboratories
name: Thomas Wolever, MD
role: PRINCIPAL_INVESTIGATOR
References: