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

This study has been completed.
Information provided by (Responsible Party):
Oliver Chen, Tufts University Identifier:
First received: September 13, 2012
Last updated: December 10, 2014
Last verified: December 2014
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.

Condition Intervention
Urinary Tract Infection
Other: cranberry juice

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Urinary Proanthocyanidin (PAC) A2 as a Biomarker of Compliance to Intake of Cranberry Products - A Pilot Study

Resource links provided by NLM:

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Proanthocyanidin A2 [ Time Frame: 24-hour urine and morning spot urine ]
    proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.

Enrollment: 5
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cranberry juice
27% cranberry juice
Other: cranberry juice
27% cranberry juice

Detailed Description:
People who frequently eat whole grains, fruits and berries, vegetables, beans and legumes, nuts, seeds, cocoa, tea, wine, and fruit or vegetable juices may have decreased risk of diseases. It is believed that some of these health benefits are due to phytochemicals present in these foods and beverages. Phytochemicals are nutrients that are naturally present in plant-based foods and beverages. Recently, cranberry containing foods and beverages are believed to prevent urinary tract infection. However, how cranberry decrease urinary tract infection is not very clear. To better understand how phytochemicals in cranberries may benefit health, we want to learn how they are absorbed and eliminated from the body. Thus, the purpose of the main study is to see whether we can measure phytochemicals from cranberries in health volunteers after they drink cranberry juice.

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any history of or known allergies to cranberries or cranberry products
  • Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements or homeopathic remedies.
  • Usual daily ethanol intake of equal and more than 2 drinks
  • Cigarette smoking and/or nicotine replacement use.
  • Strict vegetarians (vegans)
  • Pregnancy
  • Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
  • Inability to discontinue or refrain from ASA/NSAID or Tylenol use for 72 h prior to and for the duration of testing on Visits 2-13
  • Participation in a clinical research trial within 60 d of their enrollment visit (Visit 2)
  • Specific laboratory blood or urine analysis parameters of: Creatinine >1.5 mg/dL, Electrolytes, calcium, phosphorous - out of normal ranges, ALT and AST >1.5 nmol, Total bilirubin - above normal range, Fasting glucose ≥126 mg/dL, Total cholesterol >239 mg/dL, Triglycerides ≥300 mg/dL, CBC: HCT <32% for females, below normal range for males, WBC, PLT - out of normal range, hematuria, proteinuria
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Please refer to this study by its identifier: NCT01687114

United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Principal Investigator: Oliver Chen, PhD Tufts University
  More Information

Responsible Party: Oliver Chen, Research Scientist II, Tufts University Identifier: NCT01687114     History of Changes
Other Study ID Numbers: HNRC2785
Study First Received: September 13, 2012
Results First Received: November 13, 2014
Last Updated: December 10, 2014

Keywords provided by Tufts University:
compliance, proanthocyanidin, phenoic acids, cranberry

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents processed this record on April 25, 2017