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Completed

NCT Number: NCT00740077

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

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.

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Key information

Conditions

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low calorie, sugar-free cranberry juice cocktail (54% juice)

Other

Single-dose, 24 hour pharmacokinetic trial of 8 oz dose administered orally.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Ocean Spray, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 22, 2008
Registry last updated
Feb 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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