Normoglycemic, Normal Body Weight
Conditions
Keywords
Oatmeal, Beta glucan, Postprandial Glycemic Response, Blood Glucose
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.
Interventions
OTHEROatmeal
Sponsors
PepsiCo Global R&D
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose | 0-200 mins | Total area under the curve (iAUC, mmol\*min/L) for glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appetite (visual analogue scales) | 0-200 mins | Measured by VAS questionnaire at 12 time points used to calculate area under curve |
| Physical Comfort | 0-200 mins | Measured by VAS questionnaire at 12 time points used to calculate area under curve |
| Energy/Fatigue | 0-200mins | Measured by VAS questionnaire at 12 time points used to calculate area under curve |
| Palatability | at 5 mins | Measured by VAS questionnaire at 12 time points used to calculate area under curve |
Countries
Canada
Outcome results
None listed