Influences of Multivitamin Supplementation on Health Parameters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System

Conditions
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Health Behavior

Intervention / Treatment
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* Dietary Supplement: multivitamin supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multivitamin supplement<br>liquid multivitamin supplement for 12 weeks | Dietary Supplement: multivitamin supplement<br>* supplement includes 97 natural extracts<br>|
| Placebo Comparator: placebo<br>liquids with similar appearance and taste like multivitamin supplement for 12 weeks | Dietary Supplement: Placebo<br>* liquids with similar appearance and taste like multivitamin supplement for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of Vitamin B12 | vitamin B12 [pmol/l] | change measures (baseline to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of blood pressure | blood pressure | change measures (baseline to 12 weeks) | 
| Analysis of heart rate variability | heart rate variability | 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) |