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Trial record 3 of 45 for:    Completed Studies | cranberry

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687114
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):
Oliver Chen, Tufts University

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Other: cranberry juice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: cranberry juice
27% cranberry juice
Other: cranberry juice
27% cranberry juice

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01687114

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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
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Principal Investigator: Oliver Chen, PhD Tufts University
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Responsible Party: Oliver Chen, Research Scientist II, Tufts University Identifier: NCT01687114    
Other Study ID Numbers: HNRC2785
First Posted: September 18, 2012    Key Record Dates
Results First Posted: December 15, 2014
Last Update Posted: December 15, 2014
Last Verified: December 2014
Keywords provided by Oliver Chen, Tufts University:
compliance, proanthocyanidin, phenoic acids, cranberry
Additional relevant MeSH terms:
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Urinary Tract Infections
Urologic Diseases