Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778648
• Other study ID #: JPCC
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: September 9, 2010
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2010
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold

Intervention

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.
• Placebo
Four capsules of placebo daily.

Locations

Country	Name	City	State
Germany	Institute for Social medicine, Epidemiology & Health Economics	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NSA, Collierville, TN, USA

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.		within 6 months (after 2 months run-in period)	No
Secondary	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.	Yes