healthy female subjects
Conditions
Interventions
Group 1: Over a period of eight weeks, study participants have to take one pill daily of an dietary supplement. One pill contains of 250 mg magnesium, 12 mg a-TE vitamin E, 6 mg Rosavine (of 200 mg Rh
1,5 mg vitamin B2
1 mg vitamin B6
400 µg folic acid
10 µg vitamin D3
5 µg vitamin B12.
Group 2: Over a period of eight weeks, study participants have to take one pill daily of the placebo, which contains bulking agents. This pill is optical and sensorial identically eq
Sponsors
Rottapharm | Madaus GmbH - Madaus GmbH -
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: • 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.)
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Change in stress tolerance compared to placebo and within the eight-week intervention period, measured as a change in mental performance and visual attention in the Colour Word Test (CWT; Duration: 10 min) before and during an acute stress stimulus. 2. Change (compared to placebo and within 8 weeks) regarding the subjective reason-stress perception (according to the Perceived Stress Questionnaire). 3. Change (compared to placebo and within 8 weeks) regarding the subjective acute stress perception (according to the General Stress Questionnaire (ASF)) before and after an acute stress stimulus. Other control parameters for the measurement of the stress response are: cortisol and alpha-amylase in the saliva, blood pressure and heart rate. Furthermore, the following parameters and their changes are analyzed as a secondary target for all time periods (from week 0 to week 4 and week 0 to week 8): • Status of vitamins D3 and E, folic acid, vitamins B2, B6, B12 and the mineral magnesium • homocysteine | — |
Countries
Germany
Contacts
Public ContactTina Heinz
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Outcome results
None listed