- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527617
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
Intervention / Treatment
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.
Sponsor
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.
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