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

NCT ID: NCT01527617

Last Updated: 2016-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cranberry beverage

Group Type: ACTIVE_COMPARATOR

Cranberry

Intervention Type: OTHER

beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.

Non-cranberry beverage

Group Type: PLACEBO_COMPARATOR

Non-Cranberry beverage

Intervention Type: OTHER

Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.

Interventions

Cranberry

beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.

Intervention Type: OTHER

Non-Cranberry beverage

Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: collaborator

Ocean Spray, Inc.

INDUSTRY

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Washington State University

Pullman, Washington, United States

Countries

United States

Other Identifiers

IRB10178

Identifier Type: -

Identifier Source: org_study_id