Diabetes Type 2Phase 4NCT02559843
Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes
A Phase 4 study testing pomegranate juice and lifestyle modification in people with Diabetes Type 2, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- pomegranate juice and lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Nov 2014to Feb 2015
- Phase
- Phase 4
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 40-65 years
- Body Mass Index 18.5-30
- Fasting blood glucose ≥ 126 mg/dl
Who cannot join
- Smoking
- insulin for blood glucose control
- taking estrogen or progesterone (if female)
- Taking antioxidant supplements
- suffering from any other chronic diseases
- Participants are also excluded if they missed more than 10% of their pomegranate juice packs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes
Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure and oxidative stress in patients with type 2 diabetes
- Conditions
- Diabetes Type 2
- Being tested
- pomegranate juice, lifestyle modification
- Keywords
- pomegranate, diabetes, oxidative stress
- 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
lifestyle modificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| pomegranate juice | Experimental | 200 ml pomegranate juice + lifestyle modification Receives: Dietary Supplement: pomegranate juice |
| control | Active comparator | lifestyle modification including dietary recommendations Receives: Behavioral: lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
total antioxidant capacity
Measured: 6 weeks
Secondary outcomes (1)
fasting blood glucose
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559843
- Sponsor's protocol ID
- 611
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pomegranate Juice Consumption on Glycemic Control, Lipid Profile, Oxidative Stress and Blood Pressure in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02559843
- Acronym / sponsor ID
- 611
- Conditions
- Diabetes Type 2
- Keywords
- pomegranate, diabetes, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Sep 2015 (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.
Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure and oxidative stress in patients with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pomegranate juice | Experimental | Dietary Supplement: pomegranate juice200 ml pomegranate juice + lifestyle modification |
| control | Active comparator | Behavioral: lifestyle modificationlifestyle modification including dietary recommendations |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 40-65 years
- Body Mass Index 18.5-30
- Fasting blood glucose ≥ 126 mg/dl
Key exclusion criteria (6 listed)
- Smoking
- insulin for blood glucose control
- taking estrogen or progesterone (if female)
- Taking antioxidant supplements
- suffering from any other chronic diseases
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 juice | Dietary supplement | pomegranate juice |
| lifestyle modification | Behavioural | control |
Primary outcome
total antioxidant capacity
Time frame: 6 weeks
1 secondary outcome
fasting blood glucose
Time frame: 6 weeks
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 24 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pomegranate juice and lifestyle modification in people with Diabetes Type 2, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 3 inclusion and 6 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 24 Sep 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 Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
total antioxidant capacity (time frame: 6 weeks). 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 24 Sep 2015.