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In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.
The double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants.
The investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire POMS, PSS-10, SF12 & SF36. The investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multivitamin supplement | Experimental | liquid multivitamin supplement for 12 weeks |
|
| placebo | Placebo Comparator | liquids with similar appearance and taste like multivitamin supplement for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multivitamin supplement | Dietary Supplement | supplement includes 97 natural extracts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Vitamin B12 | vitamin B12 [pmol/l] | change measures (baseline to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of blood pressure | blood pressure | change measures (baseline to 12 weeks) |
| Analysis of heart rate variability | heart rate variability |
| Measure | Description | Time Frame |
|---|---|---|
| Susceptibility to infections | Documentation of diseases in disease diary | up to 12 weeks |
| assessment of life quality | use of questionnaires SF-36 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuno Hottenrott, Prof. Dr. | University of Halle-Wittenberg, Department of Sports | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Halle-Wittenberg | Halle | 06120 | Germany |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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double-blind
| Placebo | Dietary Supplement | liquids with similar appearance and taste like multivitamin supplement for 12 weeks |
|
| change measures (baseline to 12 weeks) |
| Analysis of speed of pulse wave, | speed of pulse wave | change measures (baseline to 12 weeks) |
| Plasma concentration of 25-hydroxyvitamin D | 25-hydroxyvitamin D [nmol/l] | change measures (baseline to 12 weeks) |
| Plasma concentration of folic acid | folic acid [nmol/l] | change measures (baseline to 12 weeks) |
| Plasma concentration of homocysteine | homocysteine [µmol/l] | change measures (baseline to 12 weeks) |
| Plasma concentration of HbA1c | HbA1c [mmol] | change measures (baseline to 12 weeks) |
| change measures (baseline to 12 weeks) |
| assessment of mood | use of questionnaires POMS | change measures (baseline to 12 weeks) |
| assessment of perceived stress | use of questionnaires PSS-10 | change measures (baseline to 12 weeks) |