Clinical trial NCT03909906: Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress
Official title: The Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress: a Randomised, Placebo-controlled, Double Blind Study in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Keywords: cognition
anxiety
herbal supplements
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2019-04-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Balanced crossover
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic treatment effects on anxiety following a psychological stressor
timeFrame: Following 14 days treatment
Secondary outcomes:
measure: Chronic (14 days) treatment effects on general anxiety
timeFrame: Following 14 days treatment
measure: Chronic (14 days) treatment effects on general psychological health
timeFrame: Following 14 days treatment
measure: Chronic (14 Days) treatment effects on stress
timeFrame: Following 14 days treatment
measure: Chronic (14 days) treatment effects on psychological distress
timeFrame: Following 14 days treatment
measure: Chronic (14 days) treatment effects on subjective mood as assessed by visual analogue scales following a psychological stressor
timeFrame: Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor
measure: Chronic (14 days) treatment effects on subjective ratings of stress as assessed by visual analogue scales following a psychological stressor
timeFrame: Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor
measure: Chronic (14 days) treatment effects on physiological stress responses
timeFrame: Measures taken following 14 days treatment prior to and during a psychological stressor
measure: Chronic (14 days) treatment effects on physiological stress responses
timeFrame: Measures taken following 14 days treatment prior to and during a psychological stressor
measure: Chronic (14 days) treatment effects on other physiological stress responses
timeFrame: Following 14 days treatment, measures taken at baseline, immediately before, after and then at 15, 30, 60 and 90 minutes following a psychological stressor
measure: Chronic (14 days) treatment effects on gut microbiota
timeFrame: Following 14 days treatment
measure: Chronic (14 days) treatment effects on cognitive performance during psychological stressor
timeFrame: Following 14 days treatment
measure: 7 days treatment effects on cognitive performance
timeFrame: Following 7 days treatment
measure: 13 days treatment effects on cognitive performance
timeFrame: Following 13 days treatment
measure: 7 days treatment effects on subjective ratings of mood as assessed by visual analogue scales
timeFrame: Following 7 days treatment
measure: 13 days treatment effects on subjective ratings of mood as assessed by visual analogue scales
timeFrame: Following 13 days treatment
measure: 7 days treatment effects on subjective ratings of stress as assessed by visual analogue scales
timeFrame: Following 7 days treatment
measure: 13 days treatment effects on subjective ratings of stress as assessed by visual analogue scales
timeFrame: Following 13 days treatment
measure: 7 days treatment effects on stress
timeFrame: Following 7 days treatment
measure: 13 days treatment effects on stress
timeFrame: Following 13 days treatment
measure: 7 days treatment effects on sedation
timeFrame: Following 7 days treatment
measure: 13 days treatment effects on sedation
timeFrame: Following 13 days treatment
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain performance and nutrition research centre, Northumbria university
state: Tyne And Wear
Study officials:
affiliation: Study Principal Investigator
name: Philippa Jackson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.