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

Urinary Tract Infection Clinical Trial

Official title:

Urinary Proanthocyanidin (PAC) A2 as a Biomarker of Compliance to Intake of Cranberry Products - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687114
• Other study ID #: HNRC2785
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: December 10, 2014
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Tufts Health Science Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Other:
• cranberry juice
27% cranberry juice

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proanthocyanidin A2	proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.	24-hour urine and morning spot urine	No