Efficacy of NSF on acute stress
- Conditions
- Stress
- Registration Number
- DRKS00012868
- Lead Sponsor
- MC Lab SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
healthy;
pre-menopausal women must use hormonal contraception (for 3 months or more)
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary Endpoints: Efficacy of NSF on acute stress:<br>- subjective stress, subjective anxiety and subjetive insecurity as measured by VAS-Scales before, during and after the TSST<br>- heartrate during an acute stressful situation<br>- blood pressure during an acute stressful situation<br>