Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

This study has been completed.
Sponsor:
Collaborator:
NSA, Collierville, TN, USA
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00778648
First received: October 21, 2008
Last updated: September 9, 2010
Last verified: September 2010

October 21, 2008
September 9, 2010
September 2008
July 2009   (final data collection date for primary outcome measure)
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 ]
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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00778648 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Effectiveness of an 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Common Cold
  • 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+®
  • Dietary Supplement: Placebo
    Four capsules of placebo daily.
    Other Name: -none-
  • Experimental: Juice Plus
    Intervention: Dietary Supplement: Juice Plus
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Lamprecht M, Oettl K, Schwaberger G, Hofmann P, Greilberger JF. Several indicators of oxidative stress, immunity, and illness improved in trained men consuming an encapsulated juice powder concentrate for 28 weeks. J Nutr. 2007 Dec;137(12):2737-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
543
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00778648
JPCC
No
Institute for Social Medicine, Epidemiology & Health Economics, Charite University Medical Center
Charite University, Berlin, Germany
NSA, Collierville, TN, USA
Principal Investigator: Stefan N. Willich, Prof Institute for Social Medicine, Epidemiology & Health Economics
Charite University, Berlin, Germany
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP