Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the effect of an encapsulated juice powder concentrate on the number of days with at least moderate common cold symptoms over winter time.

Detailed Description
-----------------
Common cold is the most frequent acute illness in industrialised societies. Though it is usually benign, it is a leading cause of absence from work and doctor visits, causing an enormous economic burden including lost productivity and treatment costs. Common cold is caused by a variety of viruses, with rhinoviruses and corona viruses as the most common. There is currently no treatment for common cold, thus therapy is focussed on symptom relief only. Prevention strategies for common cold include lifestyle measures such as avoiding infected people and regular hand washing during cold season. Dietary supplements including herbs and vitamins have been suggested as preventive strategies for common cold. Juice Plus+® is a dietary supplement composed primarily of juice powder concentrate and pulp from fruits and vegetables. It contains several antioxidants including vitamin C, vitamin E, beta-carotene and folate. One randomized study reported reduction in work days lost to illness in the Juice Plus+® group compared to the placebo group. However, the clinical benefit for preventing common cold symptoms has not yet been tested in a large adult population.

Official Title
-----------------
Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Dietary Supplement: Juice Plus
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male, 18-65 years of age. Able and willing to take the active or placebo capsules over the whole study period. Health care professionals with essential patient contact (physicians, nurses, physiotherapists, etc) in Berlin, Germany. Written informed consent. Exclusion Criteria: Known or suspected hypersensitivity or allergy to one of the ingredients of Juice Plus+®. Refusal to stop intake of additional vitamin supplements during study. Pregnancy or Lactation. Alcohol addiction, drug abuse or any other condition considered by the investigator to interfere with study procedures. Language limitations regarding interviews and questionnaires.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juice Plus<br> | Dietary Supplement: Juice Plus<br>* Juice Plus+® is a dietary supplement from concentrated fruits (apple, orange, pineapple,cranberry, cherry (acerola), papaya and peach) and vegetables (carrot, parsley, beet, broccoli, kale, cabbage, spinach, and tomato). Subjects will take four capsules of Juice Plus+® daily.<br>* Other names: Juice Plus+®;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Four capsules of placebo daily.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms. |  | within 6 months (after 2 months run-in period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs |  | Baseline, months 2,4,6,8. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Common cold, prevention, dietary supplement