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Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Primary Purpose

Common Cold

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Juice Plus
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Cold focused on measuring Common cold, prevention, dietary supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute for Social medicine, Epidemiology & Health Economics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Juice Plus

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.

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

Full Information

First Posted
October 21, 2008
Last Updated
September 9, 2010
Sponsor
Charite University, Berlin, Germany
Collaborators
NSA, Collierville, TN, USA
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1. Study Identification

Unique Protocol Identification Number
NCT00778648
Brief Title
Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Official Title
Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
NSA, Collierville, TN, USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Common cold, prevention, dietary supplement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Juice Plus
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice Plus
Other Intervention Name(s)
Juice Plus+®
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Four capsules of placebo daily.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan N. Willich, Prof
Organizational Affiliation
Institute for Social Medicine, Epidemiology & Health Economics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social medicine, Epidemiology & Health Economics
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18029492
Citation
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. doi: 10.1093/jn/137.12.2737.
Results Reference
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Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

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