The objective of the study is to investigate if daily oral intake of 500 mg Sokatin® improves mood and cognitive function in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
stemming en cognitief functioneren (met name geheugen en concentratie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of mood and cognitive performance using selected cognitive tests of
a computerized validated test system.
Secondary outcome
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.
Background summary
In several countries all over the world the different parts of Opuntia species
(i.e. cactus) are appreciated as a traditional and valuable food and medicine.
The genus Opuntia included about 200 species, of which Opuntia ficus indica has
the greatest economic importance. Sokatin® is an extract from the flowers of
Opuntia developed by Dr. Willmar Schwabe GmbH & Co. KG. Results of animal
studies suggest that mood or anxiety, memory and learning function may be
positively affected after intake of Sokatin®. Taking into account the main
active ingredient of Sokatin®, isorhamnetin, in particular (antioxidant)
effects on age-related decline of memory may be expected.
Study objective
The objective of the study is to investigate if daily oral intake of 500 mg
Sokatin® improves mood and cognitive function in healthy subjects.
Study design
The study is designed as an explorative, randomized, double-blind,
placebo-controlled, crossover study.
Intervention
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 wash-out period of 2 weeks in between.
Tablets have to be taken 30 to 60 minutes before breakfast.
Study burden and risks
The following burden may be experienced:
1. Blood sampling for the screening (once)
2. Filling in 2 questionnaires for screening (Health and Lifestyle
questionnaire and Anxiety scores in the STAI)
3. Visit to TNO: once for screening, 6x in study
4. Daily intake of a tablet; * to 1 h before breakfast during 16 weeks
5. Daily filling in a diary during 16 weeks
6. 4x performance of computertests
7. 6x filling in questionnaire on wellbeing
8. Weekly filling in a questionnaire on mood state (POMS)
Subjects will have their own habitual meals at home. Subjects are asked to
maintain their habitual diets. However, subjects are asked not to exceed the
amounts of fruits, vegetables and alcohol consumption as indicated by the Dutch
Food Guidelines (i.e. 200 g of vegetables and 2 portions of fruit per day, 1
glass of alcohol per day for women, 2 glasses of alcohol per day for men).
Restrictions with respect to the test days are the following:
-Good night rest the night prior to the test day;
-No alcoholic beverages the day before the test day;
-Maintain habitual coffee intake, but intake should be the same (in amount of
cups of coffee) on all the days before the test days.
Willmar Schwabe Strasse 4
PO Box 410925, D-76209 Karlsruhe
DE
Willmar Schwabe Strasse 4
PO Box 410925, D-76209 Karlsruhe
DE
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33836.028.10 |