Clinical trial NCT02651597: A Study of the Effect of Oats on Post Prandial Glucose Response
Official title: A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normoglycemic
Normal Body Weight
Keywords: Oatmeal
Beta glucan
Postprandial Glycemic Response
Blood Glucose
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
First posted: 2016-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.

Detailed description: The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (\<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited.

Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit.

Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS).

Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .

Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week.

During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.

Eligibility criteria: Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L)
* BMI= 18.5-29.9 kg/m²

Exclusion Criteria:

* A change in medication (dose or type) or medical event requiring hospitalization within the past month.
* Daily tobacco use.
* Eat meals at irregular or unusual times.
* Food allergy, aversion or unwillingness to eat study foods.
* Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
* Presence of a gastrointestinal disorder.
* Currently pregnant or lactating.

Primary outcomes:
measure: Blood Glucose
timeFrame: 0-200 mins
Secondary outcomes:
measure: Appetite (visual analogue scales)
timeFrame: 0-200 mins
measure: Physical Comfort
timeFrame: 0-200 mins
measure: Energy/Fatigue
timeFrame: 0-200mins
measure: Palatability
timeFrame: at 5 mins
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: