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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Common Cold
Interventions: Dietary Supplement: Juice Plus
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Juice Plus No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Juice Plus   Placebo
STARTED   272   271 
COMPLETED   263   266 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Juice Plus No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Juice Plus   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 272   271   543 
[Units: Years]
Mean (Standard Deviation)
 40.9  (10.2)   38.8  (10.3)   40.9  (10.2) 
[Units: Participants]
Female   202   222   424 
Male   61   44   105 
Region of Enrollment 
[Units: Participants]
Germany   272   271   543 

  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Stephanie Roll
Organization: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie , Charité - Universitätsmedizin Berlin, Germany
phone: +49 30 450 529023


Responsible Party: Institute for Social Medicine, Epidemiology & Health Economics, Charite University Medical Center Identifier: NCT00778648     History of Changes
Other Study ID Numbers: JPCC
First Submitted: October 21, 2008
First Posted: October 23, 2008
Results First Submitted: September 9, 2010
Results First Posted: October 5, 2010
Last Update Posted: October 5, 2010