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

June 1, 2016 updated by: Tufts University

The Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress in Healthy But Overweight/Obese Subjects: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
    • Washington
      • Pullman, Washington, United States, 99164
        • Washington State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cranberry beverage
beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.
Placebo Comparator: Non-cranberry beverage
Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in biomarkers of inflammation compared with placebo
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Change in biomarkers of oxidative stress compared with placebo.
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 30, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 7, 2012

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB10178

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Cranberry

3
Subscribe