Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms|
- Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms. [ Time Frame: within 6 months (after 2 months run-in period) ] [ Designated as safety issue: No ]
- Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs [ Time Frame: Baseline, months 2,4,6,8. ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Experimental: Juice Plus||
Dietary Supplement: Juice Plus
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.
Other Name: Juice Plus+®
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
Four capsules of placebo daily.
Other Name: -none-
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.
|Institute for Social medicine, Epidemiology & Health Economics|
|Berlin, Germany, 10117|
|Principal Investigator:||Stefan N. Willich, Prof||Institute for Social Medicine, Epidemiology & Health Economics|