Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

• ClinicalTrials.gov Identifier: NCT00778648
• Recruitment Status: Completed
• First Posted: October 23, 2008
• Results First Posted: October 5, 2010
• Last Update Posted: October 5, 2010
• Sponsor: Charite University, Berlin, Germany
• Collaborator: NSA, Collierville, TN, USA
• Information provided by: Charite University, Berlin, Germany

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.

Condition or disease	Intervention/treatment	Phase
Common Cold	Dietary Supplement: Juice Plus; Dietary Supplement: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 543 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
• Study Start Date: September 2008
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

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.

• Responsible Party: Institute for Social Medicine, Epidemiology & Health Economics, Charite University Medical Center
• ClinicalTrials.gov Identifier: NCT00778648
• Other Study ID Numbers: JPCC
• First Posted: October 23, 2008
• Results First Posted: October 5, 2010
• Last Update Posted: October 5, 2010
• Last Verified: September 2010

Keywords provided by Charite University, Berlin, Germany:

Common cold; prevention; dietary supplement

Additional relevant MeSH terms:

Common Cold; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases