NCT04260425

A Pilot Study Evaluating Oat Polyphenols on Post-prandial Glucose Response

A Randomized Controlled Pilot Study Evaluating the Effect of Oat Polyphenols on Post-prandial Glucose Response in Healthy Adults.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on post-prandial blood glucose response in healthy adults.

Detailed description

The clinical trial will follow a two period acute double-blind cross-over design. It will take place at Richardson Centre for Functional Food and Nutraceuticals (RCFFN) at University of Manitoba, Winnipeg, Canada. The trial will recruit healthy adult participants. Participants will consent to participate in two acute feeding sessions. Participants will be randomized to either control (low avenanthramides) then treatment (high avenanthramides) or treatment then control. Participants will arrive at the study center fasted between 8 and 10:30 am on the session days. They will be provided either the study treatment or control product based on randomization sequence for their first study visit. Baseline blood glucose (0 min) will be measured in duplicate via finger stick blood sample right before their first bite of the treatment product, and at 15, 30, 45, 60, 90 and 120 mins after baseline. The timer will be started when they take their first bite. During the second visit participant will consume the other treatment based on the randomization (the oatmeal that they didn't receive in their first visit and follow exactly the same procedure as the first visit). There will be a minimum of 5 days between sessions. Female participants will be scheduled during the luteal phase of their menstruation cycle. There will be a maximum of 8 weeks between the two sessions, therefore, participants will finish the both sessions within an 8 week period.

Conditions

• Blood Glucose

Interventions

Type	Name	Description
OTHER	Serving of oatmeal made from low avenanthramides oats and water	One serving size (40 grams dry weight) of low avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.
OTHER	Serving of oatmeal made from high avenanthramides oats and water	One serving size (40 grams dry weight) of high avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.

Timeline

• Start date: 2021-11-28
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2020-02-07
• Last updated: 2022-09-13

Locations

1 site across 1 country: Canada