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

Tufts University

Status

Completed

Conditions

Urinary Tract Infection

Treatments

Other: cranberry juice

Study type

Interventional

Funder types

Other

Identifiers

NCT01687114

HNRC2785

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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