Type 2 DiabetesNCT02024516
The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
A study testing 50 gr concentrated pomegranate juice in people with Type 2 Diabetes, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- 50 gr concentrated pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jan 2013to Dec 2013
- 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 25 to 60 years
- All sexes
- Adult
Who may be able to join
- male or female 25 to 60 years old
- having type 2 diabetes for at least 6 month
Who cannot join
- pregnancy
- lactation
- cardiac disease
- hepatic disease
- respiratory disease
- chronic renal diseases
Show all 12Show fewer
- acute or chronic inflammation
- retinopathy
- intake of antioxidant supplement
- insulin therapy
- sensitivity to concentrated pomegranate juice
- change oral drug for controlling blood glucose
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ahvaz Jundishapoor University of Medical Sciences
Ahvāz, Khoozestan
Farideh Shishebor, Nutrition PhD, +986113738319, shishehbor-f@ajums.ac.ir
Maryam Zare, MS condidate
About this study
The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.
- Conditions
- Type 2 Diabetes
- Being tested
- 50 gr concentrated pomegranate juice
- Keywords
- Type 2 diabetes, Pomegranate, Inflammation, lipid profiles
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 gr concentrated pomegranate juiceOther
| Study group | Role | What they receive |
|---|---|---|
| 50 gr concentrated pomegranate juice | Experimental | Not described Receives: Other: 50 gr concentrated pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride change
Measured: Baseline and after 4 weeks
Total Cholesterol change
Measured: Baseline and after 4 weeks
HDL- Cholesterol change
Measured: Baseline and after 4 weeks
LDL- Cholesterol change
Measured: Baseline and after 4 weeks
hsCRP change
Measured: Baseline and after 4 weeks
TNF- α change
Measured: Baseline and after 4 weeks
IL-6 change
Measured: Baseline and after 4 weeks
adiponectin change
Measured: Baseline and after 4 weeks
Secondary outcomes (3)
Fasting Blood Sugar change
Measured: baseline and after 4 weeks
Blood Pressure change
Measured: Baseline and after 4 weeks
Body Mass Index change
Measured: baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Ahvaz Jundishapur University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Zare, Ahvaz Jundishapur University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024516
- Sponsor's protocol ID
- IRCT2013091614680N1
- Status last verified
- Dec 2013
- First submitted
- 14 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02024516
- Acronym / sponsor ID
- IRCT2013091614680N1
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Pomegranate, Inflammation, lipid profiles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Ahvaz Jundishapur University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 31 Dec 2013 (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.
The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 gr concentrated pomegranate juice | Experimental | Other: 50 gr concentrated pomegranate juice |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male or female 25 to 60 years old
- having type 2 diabetes for at least 6 month
Key exclusion criteria (12 listed)
- pregnancy
- lactation
- cardiac disease
- hepatic disease
- respiratory 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 |
|---|---|---|
| 50 gr concentrated pomegranate juice | Other | 50 gr concentrated pomegranate juice |
Primary outcome
Triglyceride change
Time frame: Baseline and after 4 weeks
Total Cholesterol change
Time frame: Baseline and after 4 weeks
HDL- Cholesterol change
Time frame: Baseline and after 4 weeks
LDL- Cholesterol change
Time frame: Baseline and after 4 weeks
hsCRP change
Time frame: Baseline and after 4 weeks
TNF- α change
Time frame: Baseline and after 4 weeks
IL-6 change
Time frame: Baseline and after 4 weeks
adiponectin change
Time frame: Baseline and after 4 weeks
3 secondary outcomes
Fasting Blood Sugar change
Time frame: baseline and after 4 weeks
Blood Pressure change
Time frame: Baseline and after 4 weeks
Body Mass Index change
Time frame: baseline and after 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50 gr concentrated pomegranate juice in people with Type 2 Diabetes, run by Ahvaz Jundishapur University of Medical Sciences 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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Dec 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Zare, MS condidate (+989132275832, zare.m@ajums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride change (time frame: Baseline and after 4 weeks). The study lists 8 primary outcomes in all. 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 Dec 2013.