Clinical trial NCT03071796: Influences of Multivitamin Supplementation on Health Parameters
Official title: Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Plasma concentration of Vitamin B12
timeFrame: change measures (baseline to 12 weeks)
Secondary outcomes:
measure: Analysis of blood pressure
timeFrame: change measures (baseline to 12 weeks)
measure: Analysis of heart rate variability
timeFrame: change measures (baseline to 12 weeks)
measure: Analysis of speed of pulse wave,
timeFrame: change measures (baseline to 12 weeks)
measure: Plasma concentration of 25-hydroxyvitamin D
timeFrame: change measures (baseline to 12 weeks)
measure: Plasma concentration of folic acid
timeFrame: change measures (baseline to 12 weeks)
measure: Plasma concentration of homocysteine
timeFrame: change measures (baseline to 12 weeks)
measure: Plasma concentration of HbA1c
timeFrame: change measures (baseline to 12 weeks)
Other outcomes:
measure: Susceptibility to infections
timeFrame: up to 12 weeks
measure: assessment of life quality
timeFrame: change measures (baseline to 12 weeks)
measure: assessment of mood
timeFrame: change measures (baseline to 12 weeks)
measure: assessment of perceived stress
timeFrame: change measures (baseline to 12 weeks)
Locations:
city: Halle (Saale)
country: Germany
facility: University of Halle-Wittenberg
Study officials:
affiliation: University of Halle-Wittenberg, Department of Sports
name: Kuno Hottenrott, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: