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Completed

NCT Number: NCT00668954

Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus

This is a research study designed to look at how pomegranate juice (or a placebo juice) affects the body through the measurement of specific biomarkers, which are indicators of health.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver Center for Human Nutrition

Denver, Colorado, 80220, United States

About this study

This research study will evaluate how pomegranate juice (or a placebo juice) affects the body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers, which are indicators of health, will be measured throughout the study. They are present in blood and urine. The placebo is a juice that is not made from pomegranates, but resembles pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of general health. The investigators want to know if drinking pomegranate juice daily for 12 weeks is effective at improving a variety of biomarkers in diabetic adults.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to speak and read English
  • Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication
  • Have an HbA1C level ≤9.0% at Screening
  • Have an hsCRP level ≥ 1.0 at Screening
  • 35 - 70 years old (inclusive)
  • Non-smokers
  • Willing to maintain his/her normal activity and eating patterns for the duration of the study
  • Willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)

Exclusion criteria

  • Allergy to pomegranates
  • Currently using insulin
  • Currently taking steroidal drugs
  • HIV positive or AIDS
  • Chronic infectious disease
  • Recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
  • Cancer treated within the past two years
  • Participation in a therapeutic research study within 30 days of baseline
  • Women who are pregnant, lactating, or planning to become pregnant during the study period

Treatment and study plan

Pomegranate Juice

Dietary Supplement

Group A drinks 8 oz. pomegranate juice/day for 12 weeks

Placebo Juice

Dietary Supplement

Group B drinks 8 oz. placebo juice/day for 12 weeks

Primary outcomes

  1. Percent change of oxidant stress and lipid oxidation

    Time frame: baseline, week 6, week 12

Secondary outcomes

  1. HbA1c

    Time frame: baseline, week 6, week 12

  2. High Sensitivity C-reactive protein HsCRP

    Time frame: baseline, week 6, week 12

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • POM Wonderful LLC

Registry information

Official study title

Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 29, 2008
Registry last updated
Jul 31, 2015

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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