Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress

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.

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