Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00778648
Recruitment Status : Completed
First Posted : October 23, 2008
Results First Posted : October 5, 2010
Last Update Posted : October 5, 2010
NSA, Collierville, TN, USA
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Common Cold Dietary Supplement: Juice Plus Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00778648

Institute for Social medicine, Epidemiology & Health Economics
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
NSA, Collierville, TN, USA
Principal Investigator: Stefan N. Willich, Prof Institute for Social Medicine, Epidemiology & Health Economics

Responsible Party: Institute for Social Medicine, Epidemiology & Health Economics, Charite University Medical Center Identifier: NCT00778648     History of Changes
Other Study ID Numbers: JPCC
First Posted: October 23, 2008    Key Record Dates
Results First Posted: October 5, 2010
Last Update Posted: October 5, 2010
Last Verified: September 2010

Keywords provided by Charite University, Berlin, Germany:
Common cold
dietary supplement

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases