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

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Other: Non-Cranberry beverage; Other: Cranberry

• Registration Number: NCT01527617
• Lead Sponsor: Tufts University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-30
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-07
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-cranberry beverage	Non-Cranberry beverage	-
Cranberry beverage	Cranberry	-

Primary Outcome Measures

Name	Time	Method
Change in biomarkers of oxidative stress compared with placebo.	Baseline and 8 weeks
Change in biomarkers of inflammation compared with placebo	Baseline and 8 weeks

Trial Locations

Locations (2)

Washington State University; 🇺🇸 Pullman, Washington, United States

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States