Trials / Completed
CompletedNCT03689348
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
Acute and Chronic (28 Days) Effects of Avena Sativa Extract on Physiological and Psychological Responses to Stress, and Mood and Cognitive Function
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Northumbria University · Academic / Other
- Sex
- All
- Age
- 35 Years – 65 Years
- Healthy volunteers
- Accepted
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 N=128 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 N=128 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 training/screening 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'.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Avena sativa | A supplement derived from wild green oat |
| DIETARY_SUPPLEMENT | Placebo | Maltodextrin |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2019-09-24
- Completion
- 2019-09-24
- First posted
- 2018-09-28
- Last updated
- 2020-03-17
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03689348. Inclusion in this directory is not an endorsement.