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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
31
(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)
Placebo comparator
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Chronic treatment effects on anxiety following a psychological stressor
Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale
Time frame: Following 14 days treatment
Chronic (14 days) treatment effects on general anxiety
Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - Trait subscale
Time frame: Following 14 days treatment
Chronic (14 days) treatment effects on general psychological health
Ratings of general psychological health as defined by the General Health Questionnaire (GHQ-12)
Time frame: 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)
Time frame: Following 14 days treatment
Chronic (14 days) treatment effects on psychological distress
Ratings of stress as defined by the Profile of Mood States (POMS)
Time frame: 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)
Time frame: 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
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Ratings of stress (scored along a 100mm line)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Following 7 days treatment
13 days treatment effects on cognitive performance
Tasks include simple reaction time, digit vigilance, stroop, RVIP, peg and ball tasks
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Following 13 days treatment