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Completed

NCT Number: NCT00778648

Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Social medicine, Epidemiology & Health Economics

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Juice Plus

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.

Other names: Juice Plus+®

Placebo

Dietary Supplement

Four capsules of placebo daily.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • NSA, Collierville, TN, USA

Registry information

Official study title

Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 23, 2008
Registry last updated
Oct 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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