MoodNCT03909906
Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress
A study testing Euphytose® in people with Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- Euphytose®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2019to 18 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: 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.
Read the 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.
- Conditions
- Mood
- Being tested
- Euphytose®, Placebo Oral Tablet
- Keywords
- cognition, anxiety, herbal supplements
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euphytose®Drug
(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)
Placebo Oral TabletDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Euphytose® | Active comparator | Euphytose® 2 tablets 3 times per day for 14 days Receives: Drug: Euphytose® |
| Placebo | Placebo comparator | Matched placebo 2 tablets, 3 times per day for 14 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic treatment effects on anxiety following a psychological stressor
Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale
Measured: Following 14 days treatment
Secondary outcomes (21)
Chronic (14 days) treatment effects on general anxiety
Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - Trait subscale
Measured: 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)
Measured: 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)
Measured: Following 14 days treatment
Chronic (14 days) treatment effects on psychological distress
Ratings of stress as defined by the Profile of Mood States (POMS)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Following 7 days treatment
13 days treatment effects on cognitive performance
Tasks include simple reaction time, digit vigilance, stroop, RVIP, peg and ball tasks
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Following 13 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start3 Apr 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoodStudies 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
- Crossover
- Model description
- Balanced crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Philippa Jackson, Northumbria University
- Investigators
- Philippa Jackson, Dr, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909906
- Sponsor's protocol ID
- 9BW1
- Status last verified
- Mar 2020
- First submitted
- 4 Apr 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35875924
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress: a Randomised, Placebo-controlled, Double Blind Study in Healthy Humans
- ClinicalTrials.gov ID
- NCT03909906
- Acronym / sponsor ID
- 9BW1
- Conditions
- Mood
- Keywords
- cognition, anxiety, herbal supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 10 Apr 2019 (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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Balanced crossover
| Arm | Type | Receives |
|---|---|---|
| Euphytose® | Active comparator | Drug: Euphytose®Euphytose® 2 tablets 3 times per day for 14 days |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletMatched placebo 2 tablets, 3 times per day for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (28 listed)
- 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)
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 |
|---|---|---|
| Euphytose®(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.) | Drug | Euphytose® |
| Placebo Oral TabletPlacebo comparator | Drug | Placebo |
Primary outcome
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
21 secondary outcomes
Chronic (14 days) treatment effects on general anxiety
Time frame: Following 14 days treatment
Chronic (14 days) treatment effects on general psychological health
Time frame: Following 14 days treatment
Chronic (14 Days) treatment effects on stress
Time frame: Following 14 days treatment
Chronic (14 days) treatment effects on psychological distress
Time frame: 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
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
Chronic (14 days) treatment effects on physiological stress responses
Time frame: 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
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
Chronic (14 days) treatment effects on gut microbiota
Time frame: Following 14 days treatment
Chronic (14 days) treatment effects on cognitive performance during psychological stressor
Time frame: Following 14 days treatment
7 days treatment effects on cognitive performance
Time frame: Following 7 days treatment
13 days treatment effects on cognitive performance
Time frame: 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
13 days treatment effects on subjective ratings of mood as assessed by visual analogue scales
Time frame: 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
13 days treatment effects on subjective ratings of stress as assessed by visual analogue scales
Time frame: Following 13 days treatment
7 days treatment effects on stress
Time frame: Following 7 days treatment
13 days treatment effects on stress
Time frame: Following 13 days treatment
7 days treatment effects on sedation
Time frame: Following 7 days treatment
13 days treatment effects on sedation
Time frame: Following 13 days treatment
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 3 Mar 2020.
- Derived from this study: PubMed 35875924Dodd 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.
- Individual participant dataSharing planned: No
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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.
Philippa Jackson, Dr principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Euphytose® in people with Mood, 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 9 inclusion and 28 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 3 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?
Chronic treatment effects on anxiety following a psychological stressor (time frame: Following 14 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909906, which also lists 1 linked publication.
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 3 Mar 2020.