Clinical Trial: Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
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 Summary:
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.
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: 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) ]
Original Primary Outcome: 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 [ Time Frame: Common cold symptoms will be documented by participants with the common cold questionnaire during the study period. ]
Current Secondary Outcome: 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. ]
Original Secondary Outcome: Same as current
Information By: Charite University, Berlin, Germany
Dates:
Date Received: October 21, 2008
Date Started: September 2008
Date Completion:
Last Updated: September 9, 2010
Last Verified: September 2010
