Stress
Conditions
Interventions
Group 1: Treatmentgroup
NSF (No Stress Flash - active ingredients: Lactium und ETAS) on visit 1 and 2 respectively 2 tablets, oral, controlled intake.
Group 2: Placebogroup
From a previous study with
Sponsors
NMC Lab SAS
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: healthy; pre-menopausal women must use hormonal contraception (for 3 months or more)
Exclusion criteria
Exclusion criteria: - smoker (> 5 cigarettes / day) - any known allergies to the test substances - any known addiction to drugs and alcohol - hyper- or hypotension (except for those whose blood pressure is stable using medication for more than 3 months) - known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months) - intake of dietary supplements or homoeopathic remedies during 2 weeks before V1 - on a strict diet or practicing sport, extensively - any other known current/acute or chronic physical or psychological diseases besides minor medical conditions (e.g. seasonal allergies) - subjects having previously participated in the TSST - pregnant or lactating females or females planning a pregnancy within the next 3 months - post-menopausal women using hormonal medication for less than 3 months - employee of the sponsor or Clinical Research Organization (CRO) - Investigator doubts truthfulness of self-reported health information - not suitable because of limited verbal and cognitive abilities - on vacation within the last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint of the Study is to evaluate the efficacy of NSF on acute stress. Efficacy is defined as a dampened cortisol increase in response to the TSST and as compared to a matched control population. The TSST (Trier Social Stress Test) takes place on visit 2 and 6 saliva samples are collected in total (TSST - 2min, TSST + 1min, + 10min, + 20min, + 30min, + 45min). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Efficacy of NSF on acute stress: - subjective stress, subjective anxiety and subjetive insecurity as measured by VAS-Scales before, during and after the TSST - heartrate during an acute stressful situation - blood pressure during an acute stressful situation | — |
Countries
Germany
Contacts
Public ContactJuliane Hellhammer
daacro GmbH & Co. KG
Outcome results
None listed