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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pomegranate Juice
Placebo Juice
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Pomegranate, Biomarkers, Antioxidant

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver Center for Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pomegranate Juice

Placebo Juice (non-Pomegranate)

Arm Description

Outcomes

Primary Outcome Measures

Percent change of oxidant stress and lipid oxidation

Secondary Outcome Measures

HbA1c
High Sensitivity C-reactive protein HsCRP

Full Information

First Posted
April 25, 2008
Last Updated
July 29, 2015
Sponsor
University of Colorado, Denver
Collaborators
POM Wonderful LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00668954
Brief Title
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
Official Title
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
POM Wonderful LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Pomegranate, Biomarkers, Antioxidant

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomegranate Juice
Arm Type
Active Comparator
Arm Title
Placebo Juice (non-Pomegranate)
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate Juice
Intervention Description
Group A drinks 8 oz. pomegranate juice/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Juice
Intervention Description
Group B drinks 8 oz. placebo juice/day for 12 weeks
Primary Outcome Measure Information:
Title
Percent change of oxidant stress and lipid oxidation
Time Frame
baseline, week 6, week 12
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
baseline, week 6, week 12
Title
High Sensitivity C-reactive protein HsCRP
Time Frame
baseline, week 6, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James O. Hill, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver Center for Human Nutrition
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

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

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