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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The aim of this study is to assess the chronic effects (14 days) of Euphytose® on psychological state, physiological stress responses and any resulting changes in gut microflora communities as compared to placebo.
The aim of the proposed study is to assess the effects of chronic (14 days) supplementation with Euphytose® on psychological state with regards perceived stress and overall mood as well as psychological and physiological stress responses during a laboratory stressor. The trial will employ the Observed Multitasking Stressor (OMS), with psychological state and physiological responses assessed before and after its completion. The main mood/psychological stressor assessment will take place pre-treatment and following 14 days of treatment. Stool samples will also be collected from participants in order to assess changes in gut microflora communities at visits 1 and 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euphytose® | Active Comparator | Euphytose® 2 tablets 3 times per day for 14 days |
|
| Placebo | Placebo Comparator | Matched placebo 2 tablets, 3 times per day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euphytose® | Drug | (50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic treatment effects on anxiety following a psychological stressor | Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale | Following 14 days treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic (14 days) treatment effects on general anxiety | Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - Trait subscale | Following 14 days treatment |
| Chronic (14 days) treatment effects on general psychological health |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa Jackson, Dr | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain performance and nutrition research centre, Northumbria university | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35875924 | Derived | Dodd F, Kennedy D, Wightman E, Khan J, Patan M, Elcoate R, Jackson P. The chronic effects of a combination of herbal extracts (Euphytose(R)) on psychological mood state and response to a laboratory stressor: A randomised, placebo-controlled, double blind study in healthy humans. J Psychopharmacol. 2022 Nov;36(11):1243-1256. doi: 10.1177/02698811221112933. Epub 2022 Jul 23. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Balanced crossover
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Triple masking (Participant, investigator, outcomes assessor)
| Placebo Oral Tablet | Drug | Placebo comparator |
|
Ratings of general psychological health as defined by the General Health Questionnaire (GHQ-12)
| Following 14 days treatment |
| Chronic (14 Days) treatment effects on stress | Ratings of stress as defined by the Perceived Stress Scale (PSS) (Total score 0-40) | Following 14 days treatment |
| Chronic (14 days) treatment effects on psychological distress | Ratings of stress as defined by the Profile of Mood States (POMS) | Following 14 days treatment |
| Chronic (14 days) treatment effects on subjective mood as assessed by visual analogue scales following a psychological stressor | Ratings of mood (scored along a 100mm line) | Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor |
| Chronic (14 days) treatment effects on subjective ratings of stress as assessed by visual analogue scales following a psychological stressor | Ratings of stress (scored along a 100mm line) | Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor |
| Chronic (14 days) treatment effects on physiological stress responses | Measuring readings of galvanic skin response to determine response to psychological stressor | Measures taken following 14 days treatment prior to and during a psychological stressor |
| Chronic (14 days) treatment effects on physiological stress responses | Measuring readings of heart rate response to determine response to psychological stressor | Measures taken following 14 days treatment prior to and during a psychological stressor |
| Chronic (14 days) treatment effects on other physiological stress responses | Measuring salivary cortisol and a-amylase to determine response to psychological stressor | Following 14 days treatment, measures taken at baseline, immediately before, after and then at 15, 30, 60 and 90 minutes following a psychological stressor |
| Chronic (14 days) treatment effects on gut microbiota | Measuring changes in gut microflora communities | Following 14 days treatment |
| Chronic (14 days) treatment effects on cognitive performance during psychological stressor | Tasks include serial 3s, serial 7s, serial 17s, tracking task | Following 14 days treatment |
| 7 days treatment effects on cognitive performance | Tasks include simple reaction time, digit vigilance, stroop, Rapid Visual Information Processing (RVIP), peg and ball tasks | Following 7 days treatment |
| 13 days treatment effects on cognitive performance | Tasks include simple reaction time, digit vigilance, stroop, RVIP, peg and ball tasks | Following 13 days treatment |
| 7 days treatment effects on subjective ratings of mood as assessed by visual analogue scales | Ratings of mood (scored along a 100mm line) | Following 7 days treatment |
| 13 days treatment effects on subjective ratings of mood as assessed by visual analogue scales | Ratings of mood (scored along a 100mm line) | Following 13 days treatment |
| 7 days treatment effects on subjective ratings of stress as assessed by visual analogue scales | Ratings of stress (scored along a 100mm line) | Following 7 days treatment |
| 13 days treatment effects on subjective ratings of stress as assessed by visual analogue scales | Ratings of stress (scored along a 100mm line) | Following 13 days treatment |
| 7 days treatment effects on stress | Ratings of stress as defined by the Perceived Stress Scale (PSS) (Total score 0-40) | Following 7 days treatment |
| 13 days treatment effects on stress | Ratings of stress as defined by the Perceived Stress Scale (PSS) (Total score 0-40) | Following 13 days treatment |
| 7 days treatment effects on sedation | Ratings of subjective drowsiness as as defined by the Karolinska Sleepiness Scale (KSS) (Total score 1-10) | Following 7 days treatment |
| 13 days treatment effects on sedation | Ratings of subjective drowsiness as as defined by the Karolinska Sleepiness Scale (KSS)(Total score 1-10) | Following 13 days treatment |