Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Apr 2008
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJuly 31, 2015
July 1, 2015
1 year
April 25, 2008
July 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change of oxidant stress and lipid oxidation
baseline, week 6, week 12
Secondary Outcomes (2)
HbA1c
baseline, week 6, week 12
High Sensitivity C-reactive protein HsCRP
baseline, week 6, week 12
Study Arms (2)
Pomegranate Juice
ACTIVE COMPARATORPlacebo Juice (non-Pomegranate)
PLACEBO COMPARATORInterventions
Group A drinks 8 oz. pomegranate juice/day for 12 weeks
Group B drinks 8 oz. placebo juice/day for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- POM Wonderful LLCcollaborator
Study Sites (1)
University of Colorado Denver Center for Human Nutrition
Denver, Colorado, 80220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James O. Hill, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 29, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2009
Study Completion
November 1, 2010
Last Updated
July 31, 2015
Record last verified: 2015-07