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

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranberry
Non-Cranberry beverage
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cranberry beverage

Non-cranberry beverage

Arm Description

Outcomes

Primary Outcome Measures

Change in biomarkers of inflammation compared with placebo
Change in biomarkers of oxidative stress compared with placebo.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2012
Last Updated
June 1, 2016
Sponsor
Tufts University
Collaborators
Washington State University, Ocean Spray, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01527617
Brief Title
Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
Washington State University, Ocean Spray, Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cranberry beverage
Arm Type
Active Comparator
Arm Title
Non-cranberry beverage
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Cranberry
Intervention Description
beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.
Intervention Type
Other
Intervention Name(s)
Non-Cranberry beverage
Intervention Description
Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.
Primary Outcome Measure Information:
Title
Change in biomarkers of inflammation compared with placebo
Time Frame
Baseline and 8 weeks
Title
Change in biomarkers of oxidative stress compared with placebo.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Washington State University
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164
Country
United States

12. IPD Sharing Statement

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

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