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

This study has been completed.
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: July 29, 2015
Last verified: July 2015

April 25, 2008
July 29, 2015
April 2008
April 2009   (final data collection date for primary outcome measure)
Percent change of oxidant stress and lipid oxidation [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668954 on ClinicalTrials.gov Archive Site
  • 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 ]
  • HbA1c [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
  • HsCRP [ Time Frame: baseline, week 6, week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Dietary Supplement: Pomegranate Juice
    Group A drinks 8 oz. pomegranate juice/day for 12 weeks
  • Dietary Supplement: Placebo Juice
    Group B drinks 8 oz. placebo juice/day for 12 weeks
  • Active Comparator: Pomegranate Juice
    Intervention: Dietary Supplement: Pomegranate Juice
  • Placebo Comparator: Placebo Juice (non-Pomegranate)
    Intervention: Dietary Supplement: Placebo Juice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
November 2010
April 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668954
07-0878
No
University of Colorado, Denver
University of Colorado, Denver
POM Wonderful LLC
Principal Investigator: James O. Hill, PhD University of Colorado, Denver
University of Colorado, Denver
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP