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Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress

This study is not yet open for participant recruitment.
Verified February 2012 by Tufts University
Sponsor:
Collaborators:
Washington State University
Ocean Spray, Inc.
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01527617
First received: January 30, 2012
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.


Condition Intervention
Inflammation
 Other: Cranberry
Other: Non-Cranberry beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress in Healthy But Overweight/Obese Subjects: A Randomized Clinical Trial

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Change in biomarkers of inflammation compared with placebo [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change in biomarkers of oxidative stress compared with placebo. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cranberry beverage Other: Cranberry
beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.
Placebo Comparator: Non-cranberry beverage Other: Non-Cranberry beverage
Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men & women, aged 30-70 years
  • BMI 27-34.9 kg/m2
  • waist:hip ratio > 0.8 for women and > 0.9 for men

Exclusion Criteria:

  • Cigarette smoking and/or nicotine replacement use within last 6 months
  • Individuals taking estrogen or testosterone
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Regular use (> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
  • Cardiovascular (heart) disease
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, untreated thyroid disease
  • Rheumatoid arthritis
  • Immune deficiency conditions
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure > 139 mmHg and/or diastolic blood pressure > 89 mmHg
  • Regular use of systemic steroids, oral or injectable
  • Regular daily intake of ≥ 2 alcoholic drinks
  • Infrequent (< 3/week) or excessive (> 3/d) number of regular bowel movements
  • Gain or loss of ≥ 5% of body weight in the last 6 months
  • Pregnancy
  • Strict vegetarians
  • No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527617

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact: Diane L. McKay, PhD     781-608-7183     diane.mckay@tufts.edu    
Contact: Jeffrey B. Blumberg, PhD     617-556-3334     jeffrey.blumberg@tufts.edu    
United States, Washington
Washington State University Not yet recruiting
Pullman, Washington, United States, 99164
Contact: Boon Chew, PhD     509-335-1427     boonchew@wsu.edu    
Sponsors and Collaborators
Tufts University
Washington State University
Ocean Spray, Inc.
  More Information

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01527617     History of Changes
Other Study ID Numbers: IRB10178
Study First Received: January 30, 2012
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013