- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687114
Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products
December 10, 2014 updated by: Oliver Chen, Tufts University
Urinary Proanthocyanidin (PAC) A2 as a Biomarker of Compliance to Intake of Cranberry Products - A Pilot Study
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Jean Mayer USDA Human Nutrition Research Center on Aging
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cranberry juice
27% cranberry juice
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27% cranberry juice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proanthocyanidin A2
Time Frame: 24-hour urine and morning spot urine
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proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.
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24-hour urine and morning spot urine
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
September 13, 2012
First Submitted That Met QC Criteria
September 13, 2012
First Posted (Estimate)
September 18, 2012
Study Record Updates
Last Update Posted (Estimate)
December 15, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNRC2785
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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