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Micronutrient Supplementation and Incidence of Common Cold

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Green Beat
Sponsor:
Collaborator:
Medical University of Graz
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat
ClinicalTrials.gov Identifier:
NCT02119143
First received: April 17, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

This study investigates the effects of a dietary supplement - a cocktail of vitamins and minerals - on the incidence of common cold in a cohort of middle management employees.The primary outcome is defined as the number of duty days lost due to common cold/flu. Further, immune parameters and markers of redox biology/oxidative stress will be determined. The wellbeing in the cohort will be evaluated via questionnaires.


Condition Intervention
Immune System Diseases
Dietary Supplement: vitamines and minerals
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Micronutrient Supplementation on Duty Days Lost Due to Flu/Common Cold, Immune System, Oxidative Stress and Wellbeing in a Cohort of Middle Management Employees

Resource links provided by NLM:


Further study details as provided by Green Beat:

Primary Outcome Measures:
  • Incidence of common cold [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    vitamins and minerals might influence the incidence of common cold in middle aged management employees


Secondary Outcome Measures:
  • change in immune markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention


Other Outcome Measures:
  • change in redox biology [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    micronutrients may influence redox biology of subjects


Estimated Enrollment: 82
Study Start Date: April 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamines and minerals
41 middel aged subjects receive vitamin and mineral supplementation
Dietary Supplement: vitamines and minerals
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
Placebo Comparator: cellulose
41 middle aged subjects get the placebo
Dietary Supplement: placebo
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Detailed Description:

randomized, double-blinded, placebo controlled trial 82 Subjects, men and women, 25 - 50 yrs, non-smokers, employees of middle management, 24 weeks of supplementation/placebo, 4 wk wash-out of all supplements and dietetic products, undersupply of fruit, vegetables (< 4 portions/day) and whole grain food (< 5x/wk)

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pre or peri-menopausal
  • non-smokers
  • sedentary or moderately trained
  • BMI: >20 and < 35kg/m2
  • undersupply of fruits, vegetables and whole grain food, fibres
  • contraceptives
  • wash-out

Exclusion Criteria:

  • post-menopausal
  • smokers
  • trained people
  • BMI out of inclusion range
  • adequate intake of vegetables, fruits and whole grain food, fibres
  • no adherence to wash-out
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119143

Contacts
Contact: Manfred Lamprecht, Prof +436641555528 manfred.lamprecht@medunigraz.at

Locations
Austria
Institute of Pathophysiology and Immunology Recruiting
Graz, Styria, Austria, 8010
Contact: Sandra Wallner-Liebmann, Prof    +433163804292    sandra.wallner@medunigraz.at   
Sub-Investigator: Sandra Wallner-Liebmann, Prof         
Sponsors and Collaborators
Green Beat
Medical University of Graz
Investigators
Principal Investigator: Manfred Lamprecht, Prof Green Beat and Medical University of Graz
  More Information

No publications provided

Responsible Party: Lamprecht Manfred PhD, PhD, Principal Investigator, Green Beat
ClinicalTrials.gov Identifier: NCT02119143     History of Changes
Other Study ID Numbers: 26-151 ex 13/14
Study First Received: April 17, 2014
Last Updated: April 17, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Green Beat:
common cold, immunity, oxidative stress

Additional relevant MeSH terms:
Immune System Diseases
Common Cold
Picornaviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Micronutrients
Trace Elements
Vitamins
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014