Bioavailability of Flavonoids and Phenolic Acids From Cranberry Juice Cocktail in Healthy Older Adults

This study has been completed.
Sponsor:
Collaborator:
Ocean Spray, Inc.
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00740077
First received: August 20, 2008
Last updated: February 6, 2009
Last verified: January 2009
  Purpose

This is a single-dose, pharmacokinetic study investigating the bioavailability of flavonoids and phenolic acids from cranberry juice cocktail and their breakdown products (in vivo metabolites) in healthy, older adults. Our hypothesis is that the compounds will be poorly but rapidly absorbed from the intestines and found in plasma and urine in extensively metabolized forms. These compounds will be rapidly cleared from plasma. Substantial amounts of unabsorbed compounds will be found in the stools.


Condition Intervention
Healthy
Other: Low calorie, sugar-free cranberry juice cocktail (54% juice)

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bioavailability of Flavonoids and Phenolic Acids From Cranberry Juice Cocktail in Healthy Older Adults

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Levels of phenolic acids and flavonoids (including anthocyanins, flavanols, flavonols, and proanthocyanidins) and their in vivo metabolites in blood, urine, and feces following cranberry juice consumption. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Low calorie, sugar-free cranberry juice cocktail (54% juice)
    Single-dose, 24 hour pharmacokinetic trial of 8 oz dose administered orally.
Detailed Description:

Cranberries are a particularly rich source of phenolic acids and polyphenols, particularly flavonoids. Among the 20 most commonly consumed fruits in the American diet, cranberries have the highest total phenol content. Health benefits attributed to cranberries include the prevention of urinary tract infections and stomach ulcers as well as improved oral hygiene. These benefits appear to be due principally to the ability of cranberries to interfere with the adhesion of some bacteria to select cell types and surfaces.

Cranberries and cranberry constituents, including several phenolic and polyphenolic compounds, have also been shown to possess antibacterial, antiviral, anti-mutagenic, anti-carcinogenic, anti-tumorigenic, anti-angiogenic, and antioxidant activities. Most of this evidence is derived from in vitro studies and animal models. The limited number of human studies available indicate these phytochemicals are bioavailable and bioactive. However, more information is required on the bioavailability and metabolism of cranberry polyphenols, as well as on the relationship between cranberry dose and duration of use, to better understand their impact on risk factors for chronic diseases.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and postmenopausal women
  • BMI 18.5-29.9 kg/m2

Exclusion Criteria:

  • Cigarette smoking and/or nicotine replacement use
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Use of any stomach acid-lowering medications
  • Cardiovascular (heart) disease
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, untreated thyroid disease
  • Rheumatoid arthritis
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 95 mm Hg
  • Regular use of oral steroids
  • Regular daily intake of 2 or more alcoholic drinks
  • Illicit drug use
  • No fish oil supplements (including cod liver oil) for one month prior to study admission
  • No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740077

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Ocean Spray, Inc.
Investigators
Principal Investigator: Jeffrey B Blumberg, PhD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Jeffrey B. Blumberg, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
ClinicalTrials.gov Identifier: NCT00740077     History of Changes
Other Study ID Numbers: PV4266
Study First Received: August 20, 2008
Last Updated: February 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
cranberry
flavonoid
phenolic acid
phytochemical
bioavailability

ClinicalTrials.gov processed this record on July 23, 2014