Trial Outcomes & Findings for Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms (NCT NCT00778648)

NCT ID: NCT00778648

Last Updated: 2010-10-05

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

543 participants

Primary outcome timeframe

within 6 months (after 2 months run-in period)

Results posted on

2010-10-05

Participant Flow

Participant milestones

Participant milestones
Measure
Juice Plus
Placebo
Overall Study
STARTED
272
271
Overall Study
COMPLETED
263
266
Overall Study
NOT COMPLETED
9
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Juice Plus
n=272 Participants
Placebo
n=271 Participants
Total
n=543 Participants
Total of all reporting groups
Age Continuous
40.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
38.8 years
STANDARD_DEVIATION 10.3 • n=7 Participants
40.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
Gender
Female
202 participants
n=5 Participants
222 participants
n=7 Participants
424 participants
n=5 Participants
Gender
Male
61 participants
n=5 Participants
44 participants
n=7 Participants
105 participants
n=5 Participants
Region of Enrollment
Germany
272 participants
n=5 Participants
271 participants
n=7 Participants
543 participants
n=5 Participants

PRIMARY outcome

Timeframe: within 6 months (after 2 months run-in period)

Outcome measures

Outcome measures
Measure
Juice Plus
n=272 Participants
Placebo
n=271 Participants
Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.
7.6 Number of days
Interval 6.5 to 8.8
9.5 Number of days
Interval 8.4 to 10.6

SECONDARY outcome

Timeframe: Baseline, months 2,4,6,8.

Outcome measures

Outcome data not reported

Adverse Events

Juice Plus

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephanie Roll

Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie , Charité - Universitätsmedizin Berlin, Germany

Phone: +49 30 450 529023

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place