Micronutrient Supplementation and Incidence of Common Cold

NCT ID: NCT02119143

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune System Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamines and minerals

41 middel aged subjects receive vitamin and mineral supplementation

Group Type ACTIVE_COMPARATOR

vitamines and minerals

Intervention Type DIETARY_SUPPLEMENT

given for 24 weeks, after 4 week wash out of all supplements and dietetic products

cellulose

41 middle aged subjects get the placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitamines and minerals

given for 24 weeks, after 4 week wash out of all supplements and dietetic products

Intervention Type DIETARY_SUPPLEMENT

placebo

given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Graz

OTHER

Sponsor Role collaborator

Green Beat

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamprecht Manfred PhD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manfred Lamprecht, Prof

Role: PRINCIPAL_INVESTIGATOR

Green Beat and Medical University of Graz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Pathophysiology and Immunology

Graz, Styria, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

26-151 ex 13/14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acute Effects on Stem Cell Surveillance
NCT07341178 NOT_YET_RECRUITING NA