Acute and Chronic Effects of Avena Sativa on Cognition and Stress (NCT03689348) | Clinical Trial Compass
CompletedNot Applicable
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
United Kingdom132 participantsStarted 2018-09-24
Plain-language 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.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must self-assess themselves as being in good health
* Aged 35 to 65 years at the time of giving consent
* In employment and/or higher education or full time child-care
Exclusion Criteria:
Participants are not eligible to take part if they:
* Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progess to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
* Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive and hormone replacement treatments for female participants where symptoms are stable and treatment will not change during the course of the study, those medications used in the treatment of arthritis, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to impede the participant's ability to perform the study assessments, participants may be able to progress to screening.
* Have high blood pressu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in mood; as assessed by the 'Profile Of Mood States' (POMS)
Timeframe: Pre-dose and post-dose on day 1 and day 29
2
Changes in mood; as assessed by the 'General Anxiety Disorder- 7' (GAD-7) questionnaire
Timeframe: Day 1, 8, 15, 22 and 29
3
Changes in mood; as assessed by the 'General Health Questionnaire' (GHQ)
Timeframe: Pre-dose and post-dose on day 1 and day 29
4
Changes in cognitive function
Timeframe: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
5
Changes in subjective stress; as assessed by the 'perceived stress scale' (PSS)
Timeframe: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
6
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
Timeframe: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29