NCT01687114

Brief Summary

This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker of cranberry intake. We hypothesize the consumption of this cranberry beverage in a progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy, nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular, endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women in this age range are particularly vulnerable to urinary tract infection. Volunteers will be asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot urine samples each will be collected from subjects during the study. Urinary PAC-A2 concentration will then be determined to validate if it can serve as a marker of compliance of cranberry juice consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

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, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 15, 2014

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

September 13, 2012

Results QC Date

November 13, 2014

Last Update Submit

December 10, 2014

Conditions

Urinary Tract Infection

Keywords

compliance, proanthocyanidin, phenoic acids, cranberry

Outcome Measures

Primary Outcomes (1)

  • Proanthocyanidin A2

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

    24-hour urine and morning spot urine

Study Arms (1)

cranberry juice

EXPERIMENTAL

27% cranberry juice

Other: cranberry juice

Interventions

cranberry juiceOTHER

27% cranberry juice

cranberry juice

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • generally healthy premenopausal women
  • aged 20-40 y
  • body mass index (BMI): 18.5-25 kg/m2
  • sexually active but not pregnant or planning to become pregnant
  • no advance plans to discontinue use of hormonal contraceptives if they are taken

You may not qualify if:

  • Use of medications known to affect lipid metabolism
  • History of a bilateral mastectomy
  • Use of medications known or suspected to influence blood pressure
  • cardiovascular diseases
  • Gastrointestinal diseases,
  • Renal or chronic kidney disease
  • Endocrine disorders
  • Rheumatologic diseases
  • Immune deficiency conditions
  • Active treatment for cancer of any type longer than 1 y
  • Systolic blood pressure \>139 mmHg and/or diastolic blood pressure \>89 mmHg
  • Regular use (more than 1x/wk) of any acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications
  • Use of any antibiotics in the last month
  • Regular use of systemic steroids, oral or injectable
  • Gain or loss of more than 5% of body weight in the last 6 mo
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Urinary Tract InfectionsPatient Compliance

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Oliver Chen
Organization
Tufts University
oliver.chen@tufts.edu
617-5563128

Study Officials

  • Oliver Chen, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist II

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2014

Last Updated

December 15, 2014

Results First Posted

December 15, 2014

Record last verified: 2014-12

Locations

US(1)