Micronutrient Supplementation and Incidence of Common Cold

Green Beat

Status: Completed

Conditions: Immune System Diseases

Treatments: Dietary Supplement: vitamines and minerals; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02119143

26-151 ex 13/14

Details and patient eligibility

About

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.

Full 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)

Enrollment: 82 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

Vitamines and minerals

Active Comparator group

Description:

41 middel aged subjects receive vitamin and mineral supplementation

Treatment:

Dietary Supplement: vitamines and minerals

cellulose

Placebo Comparator group

Description:

41 middle aged subjects get the placebo

Treatment:

Dietary Supplement: placebo