Type 2 Diabetes MellitusNCT00668954
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
A study testing Pomegranate Juice in people with Type 2 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pomegranate Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Center for Human Nutrition
Denver, Colorado, 80220
About this study
Official title: 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.
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pomegranate Juice, Placebo Juice
- Keywords
- Diabetes, Pomegranate, Biomarkers, Antioxidant
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate JuiceDietary supplement
Group A drinks 8 oz. pomegranate juice/day for 12 weeks
Placebo JuiceDietary supplement
Group B drinks 8 oz. placebo juice/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate Juice | Active comparator | Not described Receives: Dietary Supplement: Pomegranate Juice |
| Placebo Juice (non-Pomegranate) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of oxidant stress and lipid oxidation
Measured: baseline, week 6, week 12
Secondary outcomes (2)
HbA1c
Measured: baseline, week 6, week 12
High Sensitivity C-reactive protein HsCRP
Measured: baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- POM Wonderful LLC
- Responsible party
- Sponsor
- Investigators
- James O. Hill, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668954
- Sponsor's protocol ID
- 07-0878
- Status last verified
- Jul 2015
- First submitted
- 25 Apr 2008
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load
- ClinicalTrials.gov ID
- NCT00668954
- Acronym / sponsor ID
- 07-0878
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Pomegranate, Biomarkers, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- POM Wonderful LLC
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate Juice | Active comparator | Dietary Supplement: Pomegranate Juice |
| Placebo Juice (non-Pomegranate) | Placebo comparator | Dietary Supplement: Placebo Juice |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- Allergy to pomegranates
- Currently using insulin
- Currently taking steroidal drugs
- HIV positive or AIDS
- Chronic infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate JuiceGroup A drinks 8 oz. pomegranate juice/day for 12 weeks | Dietary supplement | Pomegranate Juice |
| Placebo JuiceGroup B drinks 8 oz. placebo juice/day for 12 weeks | Dietary supplement | Placebo Juice (non-Pomegranate) |
Primary outcome
Percent change of oxidant stress and lipid oxidation
Time frame: baseline, week 6, week 12
2 secondary outcomes
HbA1c
Time frame: baseline, week 6, week 12
High Sensitivity C-reactive protein HsCRP
Time frame: baseline, week 6, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James O. Hill, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate Juice in people with Type 2 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change of oxidant stress and lipid oxidation (time frame: baseline, week 6, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.