Cognitive ChangeNCT03689348
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
A study testing Avena sativa in people with Cognitive Change and Stress, Psychological, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Stress, Psychological, Mood
- What is being tested?
- Avena sativa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2018to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Acute and Chronic (28 Days) Effects of Avena Sativa Extract on Physiological and Psychological Responses to Stress, and Mood and Cognitive Function
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.
Read the 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
- Cognitive Change, Stress, Psychological, Mood
- Being tested
- Avena sativa, Placebo
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avena sativaDietary supplement
Also called Wild green oat
A supplement derived from wild green oat
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin powder is the placebo ingredient and this is encased in the same pale green capsules as the active ingredient. Participants, if in the placebo group, will consume x3 capsules of placebo per day for 28 days. Receives: Dietary Supplement: Placebo |
| 300mg Avena sativa | Experimental | If in the 300mg of Avena sativa group, participants will consume x2 placebo capsules (described above) and x1 300mg capsule of Avena sativa per day for 28 days. Receives: Dietary Supplement: Avena sativa |
| 600mg Avena sativa | Experimental | If in the 600mg of Avena sativa group, participants will consume x1 placebo capsule (described above) and x2 300mg capsule of Avena sativa per day for 28 days. Receives: Dietary Supplement: Avena sativa |
| 900mg Avena sativa | Experimental | If in the 300mg of Avena sativa group, participants will consume x3 300mg capsule of Avena sativa per day for 28 days. Receives: Dietary Supplement: Avena sativa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mood; as assessed by the 'Profile Of Mood States' (POMS)
Mood will be assessed with the profile of mood states questionnaire questionnaire and this will be completed at the start and end of the testing day on day 1 and day 29. To assess if the investigational product (IP) has changed mood a change score will be calculated (end of day minus start of day) and this will be compared between the x4 treatment groups.
Measured: Pre-dose and post-dose on day 1 and day 29
Changes in mood; as assessed by the 'General Anxiety Disorder- 7' (GAD-7) questionnaire
Mood will be assessed with the general anxiety disorder-7 questionnaire on day 1 and then again on day 8, 15, 22 and 29 of the study intervention period. Change from baseline scores will be calculated and, at each subsequent time point, scores will be compared across the x4 treatment groups to ascertain if the IP has changed mood.
Measured: Day 1, 8, 15, 22 and 29
Changes in mood; as assessed by the 'General Health Questionnaire' (GHQ)
Mood will be assessed with the general health questionnaire and this will be completed at the start and end of the testing day on day 1 and day 29. To assess if the investigational product (IP) has changed mood a change score will be calculated (end of day minus start of day) and this will be compared between the x4 treatment groups.
Measured: Pre-dose and post-dose on day 1 and day 29
Changes in cognitive function
Cognitive function will be assessed via several individual cognitive tasks (stroop, rapid visual information processing and corsi blocks) and will together provide indicators of accuracy and speed. This data will be collected at baseline, 120- and 240-minutes post-dose on day 1 and day 29. Change from baseline scores will be calculated and compared across the x4 treatment groups to ascertain if the IP has changed cognitive function.
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Changes in subjective stress; as assessed by the 'perceived stress scale' (PSS)
Subjective stress will be measured via the perceived stress scale before and after each completion of the observed multitasking stressor (OMS) on day 1 and on day 29. The change in the stress response between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed subjective perceptions of stress.
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
Subjective stress will be measured via the state, trait anxiety inventory before and after each completion of the observed multitasking stressor (OMS) on day 1 and on day 29. The change in the stress response between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed subjective perceptions of stress.
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Changes in objective stress; as assessed by salivary cortisol levels
Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary cortisol levels between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Changes in objective stress; as assessed by salivary alpha-amylase levels
Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary alpha amylase levels between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Changes in objective stress; as assessed by galvanic skin response (GSR)
Galvanic skin response (GSR) will be recorded throughout the observed multitasking stressor (OMS) and the change in GSR across the OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Changes in objective stress; as assessed by heart rate (HR)
Heart rate (HR) will be recorded throughout the observed multitasking stressor (OMS) and the change in HR across the OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response.
Measured: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start24 Sep 2018
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Anklam Extrakt
- Responsible party
- Principal investigator, Emma Wightman, Northumbria University
- Investigators
- Emma Wightman, Dr, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689348
- Sponsor's protocol ID
- 57BV1
- Status last verified
- Mar 2020
- First submitted
- 27 Sep 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be shared with the study sponsor (Anklam Extrakt) and the named investigators.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic (28 Days) Effects of Avena Sativa Extract on Physiological and Psychological Responses to Stress, and Mood and Cognitive Function
- ClinicalTrials.gov ID
- NCT03689348
- Acronym / sponsor ID
- 57BV1
- Conditions
- Cognitive Change, Stress, Psychological, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Anklam Extrakt
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin powder is the placebo ingredient and this is encased in the same pale green capsules as the active ingredient. Participants, if in the placebo group, will consume x3 capsules of placebo per day for 28 days. |
| 300mg Avena sativa | Experimental | Dietary Supplement: Avena sativaIf in the 300mg of Avena sativa group, participants will consume x2 placebo capsules (described above) and x1 300mg capsule of Avena sativa per day for 28 days. |
| 600mg Avena sativa | Experimental | Dietary Supplement: Avena sativaIf in the 600mg of Avena sativa group, participants will consume x1 placebo capsule (described above) and x2 300mg capsule of Avena sativa per day for 28 days. |
| 900mg Avena sativa | Experimental | Dietary Supplement: Avena sativaIf in the 300mg of Avena sativa group, participants will consume x3 300mg capsule of Avena sativa per day for 28 days. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avena sativaAlso: Wild green oatA supplement derived from wild green oat | Dietary supplement | 300mg Avena sativa, 600mg Avena sativa, 900mg Avena sativa |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Changes in mood; as assessed by the 'Profile Of Mood States' (POMS)
Time frame: Pre-dose and post-dose on day 1 and day 29
Mood will be assessed with the profile of mood states questionnaire questionnaire and this will be completed at the start and end of the testing day on day 1 and day 29. To assess if the investigational product (IP) has changed mood a change score will be calculated (end of day minus start of day) and this will be compared between the x4 treatment groups.
Changes in mood; as assessed by the 'General Anxiety Disorder- 7' (GAD-7) questionnaire
Time frame: Day 1, 8, 15, 22 and 29
Mood will be assessed with the general anxiety disorder-7 questionnaire on day 1 and then again on day 8, 15, 22 and 29 of the study intervention period. Change from baseline scores will be calculated and, at each subsequent time point, scores will be compared across the x4 treatment groups to ascertain if the IP has changed mood.
Changes in mood; as assessed by the 'General Health Questionnaire' (GHQ)
Time frame: Pre-dose and post-dose on day 1 and day 29
Mood will be assessed with the general health questionnaire and this will be completed at the start and end of the testing day on day 1 and day 29. To assess if the investigational product (IP) has changed mood a change score will be calculated (end of day minus start of day) and this will be compared between the x4 treatment groups.
Changes in cognitive function
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Cognitive function will be assessed via several individual cognitive tasks (stroop, rapid visual information processing and corsi blocks) and will together provide indicators of accuracy and speed. This data will be collected at baseline, 120- and 240-minutes post-dose on day 1 and day 29. Change from baseline scores will be calculated and compared across the x4 treatment groups to ascertain if the IP has changed cognitive function.
Changes in subjective stress; as assessed by the 'perceived stress scale' (PSS)
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Subjective stress will be measured via the perceived stress scale before and after each completion of the observed multitasking stressor (OMS) on day 1 and on day 29. The change in the stress response between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed subjective perceptions of stress.
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Subjective stress will be measured via the state, trait anxiety inventory before and after each completion of the observed multitasking stressor (OMS) on day 1 and on day 29. The change in the stress response between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed subjective perceptions of stress.
Changes in objective stress; as assessed by salivary cortisol levels
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary cortisol levels between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response
Changes in objective stress; as assessed by salivary alpha-amylase levels
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary alpha amylase levels between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response
Changes in objective stress; as assessed by galvanic skin response (GSR)
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Galvanic skin response (GSR) will be recorded throughout the observed multitasking stressor (OMS) and the change in GSR across the OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response
Changes in objective stress; as assessed by heart rate (HR)
Time frame: Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Heart rate (HR) will be recorded throughout the observed multitasking stressor (OMS) and the change in HR across the OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No. The IPD will be shared with the study sponsor (Anklam Extrakt) and the named investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Wightman, Dr principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avena sativa in people with Cognitive Change and Stress, Psychological, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mood; as assessed by the 'Profile Of Mood States' (POMS) (time frame: Pre-dose and post-dose on day 1 and day 29). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.