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NCT Number: NCT01527617

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

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cranberry

Other

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

Non-Cranberry Beverage

Other

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

Primary outcomes

  1. Change in biomarkers of inflammation compared with placebo

    Time frame: Baseline and 8 weeks

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

    Time frame: Baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Ocean Spray, Inc.
  • Washington State University

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2012
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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