Common Cold
Conditions
Keywords
Common cold, prevention, dietary supplement
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.
Interventions
DIETARY_SUPPLEMENTJuice 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.
DIETARY_SUPPLEMENTPlacebo
Four capsules of placebo daily.
Sponsors
NSA, Collierville, TN, USA
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Juice Plus | 272 |
| Placebo | 271 |
| Total | 543 |
Baseline characteristics
| Characteristic | Juice Plus | Placebo | Total |
|---|---|---|---|
| Age Continuous | 40.9 years STANDARD_DEVIATION 10.2 | 38.8 years STANDARD_DEVIATION 10.3 | 40.9 years STANDARD_DEVIATION 10.2 |
| Gender Female | 202 participants | 222 participants | 424 participants |
| Gender Male | 61 participants | 44 participants | 105 participants |
| Region of Enrollment Germany | 272 participants | 271 participants | 543 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 272 | 0 / 271 |
| serious Total, serious adverse events | 0 / 272 | 0 / 271 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Juice Plus | Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms. | 7.6 Number of days |
| Placebo | Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms. | 9.5 Number of days |
p-value: 0.023ANOVA
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
Time frame: Baseline, months 2,4,6,8.