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Completed

NCT Number: NCT01780922

Effect of a Single Dose of Cranberry Beverage on Inflammation and Oxidative Stress

The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WSU Bioactives Research Lab

Pullman, Washington, 99164, United States

About this study

Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men & women; aged 18-35 years
  • BMI: 19-25 kg/m2

Exclusion criteria

  • Any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness
  • Had major gastrointestinal surgery or on prescription or surgical treatment
  • Any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients
  • Regularly smoked in the previous 6 months
  • On medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment
  • Risk factors for AIDS or known HIV positive status
  • Pregnant or lactating
  • High intake of chocolate or similar high polyphenol foods
  • Regular intake of vitamin and polyphenol supplements
  • Drug and alcohol misuse
  • Currently participating or had participated in another clinical study during the previous 3 weeks
  • Donated blood in the previous 3 weeks
  • Exercise more than 3 times/week for longer than 45 min each time

Treatment and study plan

Low Calorie Cranberry Juice Cocktail

Other

Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes

Cranberry Extract Beverage

Other

Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes

Non-Cranberry Beverage

Other

Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes

Primary outcomes

  1. Reduced Glutathione (GSH) Concentrations in Red Blood Cells

    Time frame: 0, 2, 4, 8, 24 h

  2. Superoxide Dismutase (SOD) Activity in Red Blood Cells

    Time frame: 0, 2, 4, 8, 24 h

  3. Glutathione Peroxidase (GPx) Activity in Red Blood Cells

    Time frame: 0, 2, 4, 8, 24 h

  4. Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)

    Time frame: 0, 2, 4, 8, 24 h

  5. C-Reactive Protein (CRP) Concentrations in Plamsa

    Time frame: 0, 2, 4, 8, 24 h

  6. Nitric Oxide (NO) Concentrations in Plamsa

    Time frame: 0, 2, 4, 8, 24 h

  7. Interleukin-1alpha (IL-1a) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  8. Interleukin-1beta (IL-1b) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  9. Interleukin-2 (IL-2) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  10. Interleukin-4 (IL-4) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  11. Interleukin-6 (IL-6) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  12. Interleukin-8 (IL-8) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  13. Interleukin-10 (IL-10) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  14. Interferon-gamma (IFN-y) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  15. Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma

    Time frame: 0, 2, 4, 8, 24 h

  16. Urinary Anti-bacteria Adhesion Activity

    Time frame: 0, 3, 6, 9, 12, 24 h

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • Ocean Spray Cranberries, Inc.

Registry information

Official study title

Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 31, 2013
Registry last updated
Jul 8, 2014

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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