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| Name | Class |
|---|---|
| Anklam Extrakt | INDUSTRY |
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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 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'.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avena sativa | Dietary Supplement | A supplement derived from wild green oat |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29 |
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Inclusion Criteria:
Exclusion Criteria:
Participants are not eligible to take part if they:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Wightman, Dr | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Newcastle upon Tyne | NE1 8ST | United Kingdom |
The IPD will be shared with the study sponsor (Anklam Extrakt) and the named investigators.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2018 | Sep 28, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo | Dietary Supplement | Maltodextrin |
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| 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. | 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. | 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 | 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 | 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 | 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. | Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29 |