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Clinical Trials/NCT03071796
NCT03071796
Completed
Not Applicable

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

Martin-Luther-Universität Halle-Wittenberg1 site in 1 country80 target enrollmentMarch 7, 2017
ConditionsHealth Behavior

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Behavior
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Enrollment
80
Locations
1
Primary Endpoint
Plasma concentration of Vitamin B12
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2017
End Date
June 20, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kuno Hottenrott, Prof.

Prof. Dr.; University of Halle-Wittenberg, Department of Sports

Martin-Luther-Universität Halle-Wittenberg

Eligibility Criteria

Inclusion Criteria

  • healthy women and men
  • age between 30-60 years

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)

Outcomes

Primary Outcomes

Plasma concentration of Vitamin B12

Time Frame: change measures (baseline to 12 weeks)

vitamin B12 \[pmol/l\]

Secondary Outcomes

  • Analysis of blood pressure(change measures (baseline to 12 weeks))
  • Analysis of heart rate variability(change measures (baseline to 12 weeks))
  • Analysis of speed of pulse wave,(change measures (baseline to 12 weeks))
  • Plasma concentration of 25-hydroxyvitamin D(change measures (baseline to 12 weeks))
  • Plasma concentration of folic acid(change measures (baseline to 12 weeks))
  • Plasma concentration of homocysteine(change measures (baseline to 12 weeks))
  • Plasma concentration of HbA1c(change measures (baseline to 12 weeks))

Study Sites (1)

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