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

NCT ID: NCT03909906

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2019-12-18

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.

Conditions

Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Euphytose®

Euphytose® 2 tablets 3 times per day for 14 days

Group Type: ACTIVE_COMPARATOR

Euphytose®

Intervention Type: DRUG

(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)

Placebo

Matched placebo 2 tablets, 3 times per day for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo comparator

Interventions

Euphytose®

(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)

Intervention Type: DRUG

Placebo Oral Tablet

Placebo comparator

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Philippa Jackson

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippa Jackson, Dr

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Brain performance and nutrition research centre, Northumbria university

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35875924 (View on PubMed)

Other Identifiers

9BW1

Identifier Type: -

Identifier Source: org_study_id