Pomegranate Juice and Metabolic Syndrome
The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.
1 other identifier
interventional
30
1 country
1
Brief Summary
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedNovember 24, 2014
December 1, 2012
1 month
November 5, 2014
November 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in values of metabolic syndrome components at 1 week
1 week
Secondary Outcomes (1)
Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week
1 weeks
Study Arms (2)
pomegranate juice
EXPERIMENTALpomegranate juice: 500 ml
placebo
PLACEBO COMPARATORsugar + aroma+ color: 500ml
Interventions
Eligibility Criteria
You may qualify if:
- presence of ≥3 of the following diagnostic of MetS:
- serum TGs of at least 150 mg/dL,
- waist circumference of more than 102 cm (40 in) in men and more than 88 cm (35 in) in women,
- high-density lipoprotein (HDL) level less than 40 mg/dL in men and less than 50 mg/dL in women,
- blood pressure 135/85 mm Hg or higher, or
- fasting glucose 100 mg/dL or Higher
You may not qualify if:
- liver cirrhosis,
- chronic pancreatitis,
- gastrointestinal or connective diseases,
- kidney stones, or
- renal failure,
- alcohol Consumption,
- having an allergy to pomegranate juice,
- a change in diet,
- the large increase in LDL so that required drug treatment.
- use of statins of fibrates, corticosteroids, nitrates, acetyl-salicylic acid or other anti-platelet drugs, oral hypoglycemic drugs, nonsteroidal anti-inflammatory drugs, or drugs interfering with coagulation;
- pregnancy or lactation in the past 6 mo, supplementation with vitamins or antioxidants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urmia University of Medical Sciences
Urmia, +98, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
mohammad alizadeh
Urmia University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 24, 2014
Study Start
January 1, 2013
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
November 24, 2014
Record last verified: 2012-12