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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527617
• Other study ID #: IRB10178
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: June 1, 2016
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2016
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Cranberry
beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.
• Non-Cranberry beverage
Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts
United States	Washington State University	Pullman	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	Ocean Spray, Inc., Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarkers of inflammation compared with placebo		Baseline and 8 weeks	No
Primary	Change in biomarkers of oxidative stress compared with placebo.		Baseline and 8 weeks	No