stemming en cognitief functioneren (met name geheugen en concentratie) state of mind and mental capacity
Conditions
Interventions
The treatments consist of daily intake of one tablet Sokatin® for a period of
eight weeks (test) or daily intake of one placebo tablet for a period of eight
weeks (control) and vice versa with a was
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy as assessed by the - health and lifestyle questionnaire - results of the pre-study laboratory tests in blood 2. Males and females aged between 30 and 50 years at Day 01 of the study 3. Able to perform easy actions on a computer 4. Having a score >= 45 in the STAI-T at screening 5. Voluntary participation 6. Having given written informed consent 7. Willing to comply with the study procedures 8. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years 9. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion criteria
Exclusion criteria: 1.Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 2.Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances 3. Having a history of medical or surgical events that may significantly affect the study outcome, including psychiatric disorders 4. Being colour-blind 5. Use of antidepressants 6. Being hypersensitive to any ingredient of the study substances 7. Use of supplements from screening towards the end of the study 8. Being a regular user of recreational drugs 9. Alcohol consumption > 28 units/week for males and > 21 units/week for females 10. Excessive smoking (> 20 cigarettes per day) 11. Reported slimming or medically prescribed diet 12. Pregnant or lactating or wishing to become pregnant in the period of the study 13. Personnel of TNO Quality of Life, their partner and their first and second degree relatives 14. Not having a general practitioner 15. Not willing to accept information-transfer concerning participation in the study to your general practinioner 16. Not willing to accept information-transfer concerning your health, like laboratory results, findings at anamnesis and eventual adverse events to and from your general practitioner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of mood and cognitive performance using selected cognitive tests of a computerized validated test system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assesment of mood by means of a Profile of Mood States questionnaire (POMS-32) that has to be filled in by the subjects once weekly. | — |
Countries
Netherlands
Outcome results
None listed