Effect of a plant extract containing dietary supplement on psychopathologic stress reactions among healthy participants
- Conditions
- STRESSHealthy volunteers
- Registration Number
- DRKS00006008
- Lead Sponsor
- Schaper & Brümmer GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 65
• Age: 25-60 years
• Men and Women
• Non-smokers
• written consent after information about study contents and study procedure
• Ability and willingness of study participants to follow study leaders instructions
• severe chronic illness (manifest coronary heart disease, cancer, • insulin-dependent diabetes mellitus Typ I and II), severe kidney or liver diseases
•Psychological diseases (ADHS, Depression, panic, anxiety)
• food allergies, known endokrine and immunological diseases
• chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome), stomach stapling operations, gastric band
•oral mucositis, dental diseases, inflammation in the oral cavity
•Hormonal disorders, for example, hyperthyroidism and Cushing's syndrome
• heart surgery (Stent, Bypass, Heart pacemaker/ gastrointestinal surgery (not: elimination of appendix or gall bladder)
• • immediate planned surgery
• addiction to alcohol and/or drugs
•Pregnancy, lactation
•Smokers
•Persons with body mass index > 30
•Persons who are not able or not allowed to give written consent
•simultaneous participation at another clinical trial or participation within the last 30 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stress tolerance (six weeks after first examination (t6) in comparison to first examination (t0)), respectivly measured as changes of the cognitive performance and visual attentnion under stress, using the Trail Making Test (TMT), before and after an acute stress impulse.
- Secondary Outcome Measures
Name Time Method •stress tolerance (six weeks after first examination (t6) in comparison to first examination (t0)), respectively measured by changes in the cognitive performance and visuell attention in the Colour Word Test (CWT) (Duration: 10 minutes) <br>•subjective stress perception (six weeks after first examination (t6) in comparison to first examination (t0)) (according to the Perceived Stress Questionnaire)<br>•acute subjective stress perception (six weeks after first examination (t6) in comparison to first examination (t0)) (according to General Stress Questionnaire) before and after an acute stress impulse.