Clinical trial NCT03689348: Acute and Chronic Effects of Avena Sativa on Cognition and Stress
Official title: Acute and Chronic (28 Days) Effects of Avena Sativa Extract on Physiological and Psychological Responses to Stress, and Mood and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Stress, Psychological
Mood
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Anklam Extrakt
First posted: 2018-09-28
Enrollment: 132
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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'.

Eligibility criteria: 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 pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
* If still menstruating/fertile, are pregnant, seeking to become pregnant or lactating. If undergoing menopause, are not stable on medication (no adverse symptoms) for at least the last 3 months
* Have learning and/or behavioural difficulties such as dyslexia or ADHD
* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
* Smoker
* excessive caffeine intake (\>500 mg per day)
* Have relevant food intolerances/ sensitivities
* Have taken antibiotics within the past 4 weeks
* Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
* Are unable to complete all of the study assessments
* Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
* Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
* Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
* Suffers from frequent migraines that require medication (more than or equal to 1 per month)
* Sleep disorders or are taking sleep aid medication
* Any known active infections
* Does not have a bank account (required for payment)
* Does not have access to the Internet (inc via smart phone)
* Are non-compliant with regards treatment consumption

Primary outcomes:
measure: Changes in mood; as assessed by the 'Profile Of Mood States' (POMS)
timeFrame: Pre-dose and post-dose on day 1 and day 29
measure: Changes in mood; as assessed by the 'General Anxiety Disorder- 7' (GAD-7) questionnaire
timeFrame: Day 1, 8, 15, 22 and 29
measure: Changes in mood; as assessed by the 'General Health Questionnaire' (GHQ)
timeFrame: Pre-dose and post-dose on day 1 and day 29
measure: Changes in cognitive function
timeFrame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
measure: 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
measure: 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
measure: Changes in objective stress; as assessed by salivary cortisol levels
timeFrame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
measure: Changes in objective stress; as assessed by salivary alpha-amylase levels
timeFrame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
measure: Changes in objective stress; as assessed by galvanic skin response (GSR)
timeFrame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
measure: Changes in objective stress; as assessed by heart rate (HR)
timeFrame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: Emma Wightman, Dr
role: PRINCIPAL_INVESTIGATOR
References: