Clinical trial NCT00778648: Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Official title: Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Keywords: Common cold
prevention
dietary supplement
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NSA, Collierville, TN, USA
First posted: 2008-10-23
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.
timeFrame: within 6 months (after 2 months run-in period)
Secondary outcomes:
measure: Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs
timeFrame: Baseline, months 2,4,6,8.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social medicine, Epidemiology & Health Economics
Study officials:
affiliation: Institute for Social Medicine, Epidemiology & Health Economics
name: Stefan N. Willich, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.