Back to resultsMicronutrient Supplementation and Incidence of Common Cold
Primary Purpose
Immune System Diseases
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
vitamines and minerals
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Immune System Diseases focused on measuring common cold, immunity, oxidative stress
Eligibility 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
Sites / Locations
- Institute of Pathophysiology and Immunology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamines and minerals
cellulose
Arm Description
41 middel aged subjects receive vitamin and mineral supplementation
41 middle aged subjects get the placebo
Outcomes
Primary Outcome Measures
Incidence of common cold
vitamins and minerals might influence the incidence of common cold in middle aged management employees
Secondary Outcome Measures
change in immune markers
cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention
Full Information
NCT ID
NCT02119143
First Posted
April 17, 2014
Last Updated
July 29, 2017
Sponsor
Green Beat
Collaborators
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT02119143
Brief Title
Micronutrient Supplementation and Incidence of Common Cold
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Green Beat
Collaborators
Medical University of Graz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Diseases
Keywords
common cold, immunity, oxidative stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamines and minerals
Arm Type
Active Comparator
Arm Description
41 middel aged subjects receive vitamin and mineral supplementation
Arm Title
cellulose
Arm Type
Placebo Comparator
Arm Description
41 middle aged subjects get the placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamines and minerals
Intervention Description
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products
Primary Outcome Measure Information:
Title
Incidence of common cold
Description
vitamins and minerals might influence the incidence of common cold in middle aged management employees
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
change in immune markers
Description
cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
change in redox biology
Description
micronutrients may influence redox biology of subjects
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Lamprecht, Prof
Organizational Affiliation
Green Beat and Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Pathophysiology and Immunology
City
Graz
State/Province
Styria
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Micronutrient Supplementation and Incidence of Common Cold
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