- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909906
Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress
March 2, 2020 updated by: Philippa Jackson, Northumbria University
The Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress: a Randomised, Placebo-controlled, Double Blind Study in Healthy Humans
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne And Wear
-
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
- Brain performance and nutrition research centre, Northumbria university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-65 years
- In good physical health
- Subjects agree to abstain throughout the trial from all dietary supplements (note: protein shakes and garlic supplements are allowed)
- Body Mass Index above 18 kg/m2 and below 35 kg/m2
- Subjects are, in the opinion of the investigator, willing to participate in all scheduled visits and to adhere to all study procedures
- Subjects accept to refrain from alcohol intake 24 hours prior to Testing Visits 1-4
- Subjects do not have a current diagnosis of a significant medical condition which may interfere with the subject's ability to perform assessments and successfully completes training
- Subjects provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial and understood and accepts these
- Have a bank account (required for payment)
Exclusion Criteria:
- Have any pre-existing medical condition/illness? NOTE: the exceptions to this are controlled (medicated) arthritis, asthma, high cholesterol and reflux-related conditions
- Event (personal or professional) likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks (for example but not restricted to: change of professional function/situation, death of a family member, divorce, surgery, accident, etc.)
- Event (personal or professional) likely to affect the subject's emotional, psychological or hormonal state planned during the next 8 weeks, including vaccination, important medical exam etc.
- Smoking or the use of any nicotine replacement products e.g. vaping, gum, patches (smoking within the last 3 months)
- Blood pressure >159/99 millimeters of mercury (mmHg)
- Excessive use of caffeine (> 500 mg caffeine per day) from all dietary sources
- Current intake of pharmaceuticals (excluding contraception and arthritis, cholesterol and reflux-related hormone replacement treatments (for female participants) where symptoms are stable and medications do not contraindicate the study outcomes and inhalers used as required)
- Have taken antibiotics within the last 4 weeks
- Any known active infections
- Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
- A history of neurological or psychiatric diseases excluding anxiety or depression
- A diagnosis/treatment for a psychiatric disorder within the past 12 months (including anxiety or depression)
- A history of significant head trauma
- Have sleep disturbances and/or are taking sleep aid medication
- Have learning difficulties or dyslexia
- Have visual impairment that cannot be corrected with glasses or contact lenses (including colour blindness)
- Have frequent migraines that require medication (more than or equal to 1 per month)
- Not proficient in English equivalent to International English Language Testing System (IELTS) band 6 or above
- Are pregnant, trying to get pregnant or breast feeding
- Have any health condition that would prevent fulfillment of the study requirements
- Any condition which may interfere with the subjects ability to perform assessments
- Are employed in a job that includes night shift work
- Have no access to the internet (including via smartphone)
- Are unable to perform the computerized tests during training to the established acceptable levels for participation in this type of study.
- Have habitually used supplements, within the last month (defined as more than 3 consecutive days or 4 days in total)
- Participation in another clinical trial within 30 days prior to screening
- Any history of hypersensitivity to the investigational product or its active or inactive constituents or any food allergy or intolerance
- Non-compliant in terms of treatment consumption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Euphytose®
Euphytose® 2 tablets 3 times per day for 14 days
|
(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)
|
Placebo Comparator: Placebo
Matched placebo 2 tablets, 3 times per day for 14 days
|
Placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic treatment effects on anxiety following a psychological stressor
Time Frame: Following 14 days treatment
|
Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale
|
Following 14 days treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic (14 days) treatment effects on general anxiety
Time Frame: Following 14 days treatment
|
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
Time Frame: Following 14 days treatment
|
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
Time Frame: Following 14 days treatment
|
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
Time Frame: Following 14 days treatment
|
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
Time Frame: Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes 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
Time Frame: Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes 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
Time Frame: Measures taken following 14 days treatment prior to and during a psychological stressor
|
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
Time Frame: Measures taken following 14 days treatment prior to and during a psychological stressor
|
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
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
|
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
Time Frame: Following 14 days treatment
|
Measuring changes in gut microflora communities
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Following 14 days treatment
|
Chronic (14 days) treatment effects on cognitive performance during psychological stressor
Time Frame: Following 14 days treatment
|
Tasks include serial 3s, serial 7s, serial 17s, tracking task
|
Following 14 days treatment
|
7 days treatment effects on cognitive performance
Time Frame: Following 7 days treatment
|
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
Time Frame: Following 13 days treatment
|
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
Time Frame: Following 7 days treatment
|
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
Time Frame: Following 13 days treatment
|
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
Time Frame: Following 7 days treatment
|
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
Time Frame: Following 13 days treatment
|
Ratings of stress (scored along a 100mm line)
|
Following 13 days treatment
|
7 days treatment effects on stress
Time Frame: Following 7 days treatment
|
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
Time Frame: Following 13 days treatment
|
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
Time Frame: Following 7 days treatment
|
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
Time Frame: Following 13 days treatment
|
Ratings of subjective drowsiness as as defined by the Karolinska Sleepiness Scale (KSS)(Total score 1-10)
|
Following 13 days treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippa Jackson, Dr, Study Principal Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2019
Primary Completion (Actual)
December 18, 2019
Study Completion (Actual)
December 18, 2019
Study Registration Dates
First Submitted
April 4, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 9BW1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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