NCT00778648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 5, 2010

Completed
Last Updated

October 5, 2010

Status Verified

September 1, 2010

Enrollment Period

10 months

First QC Date

October 21, 2008

Results QC Date

September 9, 2010

Last Update Submit

September 9, 2010

Conditions

Common Cold

Keywords

Common coldpreventiondietary supplement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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

    Baseline, months 2,4,6,8.

Study Arms (2)

Juice Plus

EXPERIMENTAL
Dietary Supplement: Juice Plus

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Juice PlusDIETARY_SUPPLEMENT

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.

Also known as: Juice Plus+®
Juice Plus
PlaceboDIETARY_SUPPLEMENT

Four capsules of placebo daily.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Social medicine, Epidemiology & Health Economics

Berlin, State of Berlin, 10117, Germany

Location

Related 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. doi: 10.1093/jn/137.12.2737.

    PMID: 18029492BACKGROUND

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Stephanie Roll
Organization
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie , Charité - Universitätsmedizin Berlin, Germany
stephanie.roll@charite.de
+49 30 450 529023

Study Officials

  • Stefan N. Willich, Prof

    Institute for Social Medicine, Epidemiology & Health Economics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 23, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 5, 2010

Results First Posted

October 5, 2010

Record last verified: 2010-09

Locations

DE(1)