Health Behavior
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTmultivitamin supplement
supplement includes 97 natural extracts
DIETARY_SUPPLEMENTPlacebo
liquids with similar appearance and taste like multivitamin supplement for 12 weeks
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy women and men * age between 30-60 years * employed
Exclusion criteria
* acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis) * frequent use of alcohol, drugs or cigarettes (\>5 cigarettes / day) * use of additional supplements * use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Vitamin B12 | change measures (baseline to 12 weeks) | vitamin B12 \[pmol/l\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of speed of pulse wave, | change measures (baseline to 12 weeks) | speed of pulse wave |
| Plasma concentration of 25-hydroxyvitamin D | change measures (baseline to 12 weeks) | 25-hydroxyvitamin D \[nmol/l\] |
| Plasma concentration of folic acid | change measures (baseline to 12 weeks) | folic acid \[nmol/l\] |
| Plasma concentration of homocysteine | change measures (baseline to 12 weeks) | homocysteine \[µmol/l\] |
| Plasma concentration of HbA1c | change measures (baseline to 12 weeks) | HbA1c \[mmol\] |
| Analysis of blood pressure | change measures (baseline to 12 weeks) | blood pressure |
| Analysis of heart rate variability | change measures (baseline to 12 weeks) | heart rate variability |
Other
| Measure | Time frame | Description |
|---|---|---|
| assessment of mood | change measures (baseline to 12 weeks) | use of questionnaires POMS |
| assessment of perceived stress | change measures (baseline to 12 weeks) | use of questionnaires PSS-10 |
| Susceptibility to infections | up to 12 weeks | Documentation of diseases in disease diary |
| assessment of life quality | change measures (baseline to 12 weeks) | use of questionnaires SF-36 |
Countries
Germany
Outcome results
None listed