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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Tufts University
Sponsor:
Information provided by (Responsible Party):
Oliver Chen, Tufts University
ClinicalTrials.gov Identifier:
NCT01687114
First received: September 13, 2012
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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
Validate Proanthocyanidin A2 as a Compliance Marker of Cranberry Juice Consumption
Other: cranberry juice

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
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

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • proanthocyanidin A2 [ Time Frame: 24-hour urine and morning spot urine ] [ Designated as safety issue: No ]
    proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method


Estimated Enrollment: 5
Study Start Date: September 2012
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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687114

Contacts
Contact: Kimberly J. Dupiton 617-556-3012 Kimberly.Dupiton@tufts.edu

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging Active, not recruiting
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Oliver Chen, PhD Tufts University
  More Information

No publications provided

Responsible Party: Oliver Chen, Research Scientist II, Tufts University
ClinicalTrials.gov Identifier: NCT01687114     History of Changes
Other Study ID Numbers: HNRC2785
Study First Received: September 13, 2012
Last Updated: September 17, 2012
Health Authority: United States: Tufts Health Science Institutional Review Board

Keywords provided by Tufts University:
compliance

Additional relevant MeSH terms:
Proanthocyanidin
Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014