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

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cranberry juice
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Tract Infection focused on measuring compliance, proanthocyanidin, phenoic acids, cranberry

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Jean Mayer USDA Human Nutrition Research Center on Aging

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cranberry juice

Arm Description

27% cranberry juice

Outcomes

Primary Outcome Measures

Proanthocyanidin A2
proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2012
Last Updated
December 10, 2014
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT01687114
Brief Title
Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products
Official Title
Urinary Proanthocyanidin (PAC) A2 as a Biomarker of Compliance to Intake of Cranberry Products - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
compliance, proanthocyanidin, phenoic acids, cranberry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cranberry juice
Arm Type
Experimental
Arm Description
27% cranberry juice
Intervention Type
Other
Intervention Name(s)
cranberry juice
Intervention Description
27% cranberry juice
Primary Outcome Measure Information:
Title
Proanthocyanidin A2
Description
proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.
Time Frame
24-hour urine and morning spot urine

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Chen, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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

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