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

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT01527617

Collaborator

Washington State University (Other), Ocean Spray, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

39.5

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation	Other: Cranberry Other: Non-Cranberry beverage	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Cranberry beverage

Other: Cranberry

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

Placebo Comparator: Non-cranberry beverage

Other: Non-Cranberry beverage

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111
2	Washington State University	Pullman	Washington	United States	99164

Sponsors and Collaborators

Tufts University
Washington State University
Ocean Spray, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tufts University

ClinicalTrials.gov Identifier:

NCT01527617

Other Study ID Numbers:

IRB10178

First Posted:

Feb 7, 2012

Last Update Posted:

Jun 2, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Jun 2, 2016