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CompletedNCT00668954Updated Jul 31, 2015

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

An interventional study of Pomegranate Juice and Placebo Juice in Type 2 Diabetes Mellitus, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Diabetes
  • Pomegranate
  • Biomarkers
  • Antioxidant
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 26 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Browse University of Colorado, Denver studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Pomegranate Juice

    Dietary Supplement: Pomegranate Juice

  • Placebo comparator
    Placebo Juice (non-Pomegranate)

    Dietary Supplement: Placebo Juice

Interventions

  • Dietary supplementPomegranate Juice

    Group A drinks 8 oz. pomegranate juice/day for 12 weeks

  • Dietary supplementPlacebo Juice

    Group B drinks 8 oz. placebo juice/day for 12 weeks

06

What researchers measure

Primary outcomes

  1. Percent change of oxidant stress and lipid oxidation

    Time frame: baseline, week 6, week 12

Secondary outcomes

  1. HbA1c

    Time frame: baseline, week 6, week 12

  2. High Sensitivity C-reactive protein HsCRP

    Time frame: baseline, week 6, week 12

07

Study locations

1 site
  • University of Colorado Denver Center for Human Nutrition
    Denver, Colorado 80220, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2008, a primary completion of Apr 2009 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2008
First posted
Apr 29, 2008
Start
Apr 2008
Primary completionActual
Apr 2009
CompletionActual
Nov 2010
Last update
Jul 31, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00668954
Lead sponsor
University of Colorado, Denver
Collaborators
POM Wonderful LLC
Responsible party
Sponsor
First posted
Apr 29, 2008
Start date
Apr 2008
Primary completion
Apr 2009
Completion
Nov 2010
Last update
Jul 31, 2015

Study contacts

James O. Hill, PhD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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