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

Tufts University

Status: Completed

Conditions: Inflammation

Treatments: Other: Cranberry; Other: Non-Cranberry beverage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01527617

IRB10178

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups, including a placebo group

Cranberry beverage

Active Comparator group

Treatment:

Other: Cranberry

Non-cranberry beverage

Placebo Comparator group

Treatment:

Other: Non-Cranberry beverage