Trial Outcomes & Findings for Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products (NCT NCT01687114)

NCT ID: NCT01687114

Last Updated: 2014-12-15

Results Overview

proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 24-hour urine and morning spot urine
• Results posted on: 2014-12-15

Participant Flow

Participant milestones

Measure	Cranberry Juice 27% cranberry juice cranberry juice: 27% cranberry juice
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products

Baseline characteristics by cohort

Measure	Cranberry Juice n=5 Participants 27% cranberry juice cranberry juice: 27% cranberry juice
Age, Continuous	27.6 years STANDARD_DEVIATION 3.4 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 24-hour urine and morning spot urine

Population: The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.

proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.

Outcome measures

Measure	Cranberry Juice n=5 Participants 27% cranberry juice cranberry juice: 27% cranberry juice
Proanthocyanidin A2 24 h urine	0.6 ng/mg creatinine Standard Deviation 0.5
Proanthocyanidin A2 morning spot urine	0.20 ng/mg creatinine Standard Deviation 0.16

Adverse Events

Cranberry Juice

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

Oliver Chen

Tufts University

Phone: 617-5563128

Email: oliver.chen@tufts.edu

Results disclosure agreements

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