Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Effectiveness of an 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.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Dietary supplement: Juice Plus; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 543
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Institute for Social medicine, Epidemiology & Health Economics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Four capsules of placebo daily.
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 Names: Juice Plus+®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.	within 6 months (after 2 months run-in period)

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs	Baseline, months 2,4,6,8.

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: NSA, Collierville, TN, USA
• Investigators: Principal Investigator: Stefan N. Willich, Prof, Institute for Social medicine, Epidemiology & Health Economics

Publications and helpful links

General 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. doi: 10.1093/jn/137.12.2737.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimate): October 23, 2008

Study Record Updates

• Last Update Posted (Estimate): October 5, 2010
• Last Update Submitted That Met QC Criteria: September 9, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: prevention; dietary supplement; Common cold
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: JPCC