Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

NCT ID: NCT00778648

Last Updated: 2010-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Juice Plus

Group Type EXPERIMENTAL

Juice Plus

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Four capsules of placebo daily.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Four capsules of placebo daily.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Juice Plus+®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NSA, Collierville, TN, USA

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charite University Medical Center

Principal Investigators

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Stefan N. Willich, Prof

Role: PRINCIPAL_INVESTIGATOR

Institute for Social Medicine, Epidemiology & Health Economics

Locations

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Institute for Social medicine, Epidemiology & Health Economics

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 18029492 (View on PubMed)

Other Identifiers

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JPCC

Identifier Type: -

Identifier Source: org_study_id