A Study of the Effect of Oats on Post Prandial Glucose Response

Normal Body Weight Clinical Trial

Official title:

A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651597
• Other study ID #: B2015:142
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 10, 2016

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 10, 2016
• Est. primary completion date: December 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Normal Body Weight
• Normoglycemic

Intervention

Other:
• Oatmeal

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	PepsiCo Global R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose	Total area under the curve (iAUC, mmol*min/L) for glucose	0-200 mins
Secondary	Appetite (visual analogue scales)	Measured by VAS questionnaire at 12 time points used to calculate area under curve	0-200 mins
Secondary	Physical Comfort	Measured by VAS questionnaire at 12 time points used to calculate area under curve	0-200 mins
Secondary	Energy/Fatigue	Measured by VAS questionnaire at 12 time points used to calculate area under curve	0-200mins
Secondary	Palatability	Measured by VAS questionnaire at 12 time points used to calculate area under curve	at 5 mins