Viewing Study NCT03689348



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Last Modification Date: 2024-10-26 @ 12:55 PM
Study NCT ID: NCT03689348
Status: COMPLETED
Last Update Posted: 2020-03-17
First Post: 2018-09-27

Brief Title: Acute and Chronic Effects of Avena Sativa on Cognition and Stress
Sponsor: Northumbria University
Organization: Northumbria University

Study Overview

Official Title: Acute and Chronic 28 Days Effects of Avena Sativa Extract on Physiological and Psychological Responses to Stress and Mood and Cognitive Function
Status: COMPLETED
Status Verified Date: 2020-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The flavanoid and terpene phytochemicals present in wild green oat interact with multiple mechanisms relevant to brain function including those which would modulate cognition and stress The current study aims to test this in a group of N128 males and females between the ages of 35-65yrs before and after 28 days supplementation of placebo 300- 600- and 900mg of a wild green oat extract
Detailed Description: The flavanoid and terpene phytochemicals present in wild green oat interact with multiple mechanisms relevant to brain function including those which would modulate cognition and stress The current study aims to test this in a group of N128 males and females between the ages of 35-65yrs before and after 28 days supplementation of placebo 300- 600- and 900mg of a wild green oat extract The study is randomized within x3 age categories also 35-45 46-55 56-65yrs placebo controlled and counterballanced across parallel groups Participants will first attend a trainingscreening session followed by x2 lab-based testing sessions 28 days apart In the lab-based sessions participants will complete baseline cognitive assessments including whilst undergoing a stressful observed methodology the observed multi-tasking stressor or OMS Here galvanic skin response and heart rate will be measured and before and after the OMS participants will provide a saliva sample which will be analysed for cortisol and alpha-amylase levels This procedure will be repeated 120- and 240- minutes post-dose Between the lab-based sessions participants will complete mood scales via a mobile phone application cognimapp

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None