Influences of Multivitamin Supplementation on Health Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Dietary supplement: multivitamin supplement; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Halle (Saale), Germany, 06120
    • University of Halle-Wittenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: multivitamin supplement; liquid multivitamin supplement for 12 weeks	Dietary supplement: multivitamin supplement; supplement includes 97 natural extracts
PLACEBO_COMPARATOR: placebo; liquids with similar appearance and taste like multivitamin supplement for 12 weeks	Dietary supplement: Placebo; liquids with similar appearance and taste like multivitamin supplement for 12 weeks

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Investigators: Principal Investigator: Kuno Hottenrott, Prof. Dr., University of Halle-Wittenberg, Department of Sports

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2017
• Primary Completion (ACTUAL): June 15, 2017
• Study Completion (ACTUAL): June 20, 2017

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (ACTUAL): March 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ILUG-201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No