Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products
Completed · Not applicable
Conditions studied: Urinary Tract Infection
In brief
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.
Key facts
- Study ID
- NCT01687114
- Run by
- Tufts University
- People needed
- 5
- Starts
- 2012-09-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2014-12-15
Who can join
Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jean Mayer USDA Human Nutrition Research Center on Aging — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.