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

NCT03909906 | Completed

• 1 other identifier: 9BW1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood

Keywords

cognition; anxiety; herbal supplements

Outcome Measures

Primary Outcomes (1)

• Chronic treatment effects on anxiety following a psychological stressor

  Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale

  Following 14 days treatment

Secondary Outcomes (21)

• Chronic (14 days) treatment effects on general anxiety

  Following 14 days treatment

• Chronic (14 days) treatment effects on general psychological health

  Following 14 days treatment

• Chronic (14 Days) treatment effects on stress

  Following 14 days treatment

• Chronic (14 days) treatment effects on psychological distress

  Following 14 days treatment

• Chronic (14 days) treatment effects on subjective mood as assessed by visual analogue scales following a psychological stressor

  Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor

Study Arms (2)

Euphytose®

ACTIVE COMPARATOR

Euphytose® 2 tablets 3 times per day for 14 days

Drug: Euphytose®

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Euphytose® DRUG

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

Euphytose®

Placebo Oral Tablet DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Bayer: collaborator

Study Sites (1)

Brain performance and nutrition research centre, Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35875924 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Philippa Jackson, Dr

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple masking (Participant, investigator, outcomes assessor)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Balanced crossover

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 10, 2019
• Study Start: April 3, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)