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:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00668954

First received: April 25, 2008

Last updated: February 12, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

February 12, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00668954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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. We want to know if drinking pomegranate juice daily for 12 weeks is effective at improving a variety of biomarkers in diabetic adults.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: A
Intervention: Dietary Supplement: Pomegranate Juice
Placebo Comparator: B
Intervention: Dietary Supplement: Placebo Juice

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00668954

Other Study ID Numbers ^ICMJE

07-0878

Has Data Monitoring Committee

Responsible Party

James O. Hill, Ph.D., University of Colorado Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

POM Wonderful LLC

Investigators ^ICMJE

Principal Investigator:

James O. Hill, PhD

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

February 2009

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

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