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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammation

Intervention / Treatment
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* Other: Cranberry
* Other: Non-Cranberry beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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