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
  Purpose

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 Intervention
Common Cold
Dietary Supplement: Juice Plus
Dietary Supplement: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 543
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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-

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778648

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

Publications:
Responsible Party: Institute for Social Medicine, Epidemiology & Health Economics, Charite University Medical Center
ClinicalTrials.gov Identifier: NCT00778648     History of Changes
Other Study ID Numbers: JPCC
Study First Received: October 21, 2008
Results First Received: September 9, 2010
Last Updated: September 9, 2010
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 16, 2014