Effect of a nutritional supplement with vitamins, magnesium and Rhodiola rosea extract on psychophysiological stress reactions in women during periods of stress
- Conditions
- healthy female subjects
- Registration Number
- DRKS00006867
- Lead Sponsor
- Rottapharm | Madaus GmbH - Madaus GmbH -
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Female
- Target Recruitment
- 150
• Age: 20-50 years
• healthy women
• Written consent of the subjects after detailed oral and written explanation of the course content, requirements and risks
• Ability and willingness of study participants to follow the instructions of the study leader (compliance with study conditions, taking the test product according to the dosage recommendation, etc.)
• severe chronic diseases (malignant tumors, diabetes mellitus type 1 and type 2, etc.), manifest cardiovascular disease (e.g. angina pectoris, heart failure), kidney failure, liver disease
• Mental Disorders (ADHD, depression, panic attacks, anxiety, etc.)
• diagnosed bleeding disorders as well as taking anticoagulant medications e.g. warfarin (except aspirin)
• known allergy or intolerance to one of the ingredients contained in the test product
• chronic gastrointestinal disorders (ulcerative colitis, Crohn's disease, pancreatic insufficiency)
• heart surgery (stent, bypass, pacemaker) or digestive tract (exceptions: removal of appendix or gall bladder)
• inflammation of the oral cavity associated with gingival bleeding (e.g. gingivitis, periodontitis, mucositis)
• imminent surgery
• ingestion of nutrient supplements, which contain Rhodiola rosea (Rhodiola)
• taking anti-depressants, etc.
• addiction to alcohol, drugs and / or medicines
• Pregnancy and lactation
• BMI > 30 kg / m2
• incapacitated subjects
• refusal or withdrawal of consent by the subject
• Simultaneous participation in another clinical trial or to participate in the last 30 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the stress tolerance compared to placebo and within the eight-week intervention period, respectivly measured as a change in mental performance and visual attention under stress, using Trail Making Test (TMT) before and after an acute stress stimulus.
- Secondary Outcome Measures
Name Time Method