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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Colorado, Denver.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00668954
First received: April 25, 2008
Last updated: January 7, 2013
Last verified: February 2009
History of Changes
  Purpose

This is a research study designed to look at 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.


Condition Intervention
Type 2 Diabetes Mellitus
 Dietary Supplement: Pomegranate Juice
Dietary Supplement: Placebo Juice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Percent change of oxidant stress and lipid oxidation [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
  • High Sensitivity C-reactive protein HsCRP [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Study Completion Date: April 2013
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Dietary Supplement: Pomegranate Juice
Group A drinks 8 oz. pomegranate juice/day for 12 weeks
Placebo Comparator: B Dietary Supplement: Placebo Juice
Group B drinks 8 oz. placebo juice/day for 12 weeks

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668954

Locations
United States, Colorado
University of Colorado Denver Center for Human Nutrition
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
POM Wonderful LLC
Investigators
Principal Investigator: James O. Hill, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00668954     History of Changes
Other Study ID Numbers: 07-0878
Study First Received: April 25, 2008
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Diabetes
Pomegranate
Biomarkers
Antioxidant

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013