The Effect of Concentrated Pomegranate Juice Consumption... | NCT02024516

Studies
The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes

NCT02024516

Sponsor

Ahvaz Jundishapur University of Medical Sciences

Status

Unknown status

Last Update Posted

Dec 31, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

50 gr concentrated pomegranate juice

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Not provided

First Submitted Date

Dec 14, 2013

First Submission Date that Met QC Criteria

Dec 30, 2013

First Posted Date

Dec 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maryam Zare, Nutritionist, Ahvaz Jundishapur University of Medical SciencesPrincipal Investigator

Lead Sponsor

Ahvaz Jundishapur University of Medical SciencesOTHER

Collaborators

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
50 gr concentrated pomegranate juice	Experimental		Other: 50 gr concentrated pomegranate juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
50 gr concentrated pomegranate juice	Other		50 gr concentrated pomegranate juice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Triglyceride change		Baseline and after 4 weeks
Total Cholesterol change		Baseline and after 4 weeks
HDL- Cholesterol change		Baseline and after 4 weeks
LDL- Cholesterol change		Baseline and after 4 weeks
hsCRP change		Baseline and after 4 weeks
TNF- α change		Baseline and after 4 weeks
IL-6 change		Baseline and after 4 weeks
adiponectin change		Baseline and after 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fasting Blood Sugar change		baseline and after 4 weeks
Blood Pressure change		Baseline and after 4 weeks
Body Mass Index change

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female 25 to 60 years old
having type 2 diabetes for at least 6 month

Exclusion Criteria:

pregnancy
lactation
cardiac disease
hepatic disease
respiratory disease
chronic renal diseases
acute or chronic inflammation
retinopathy
intake of antioxidant supplement
insulin therapy
sensitivity to concentrated pomegranate juice
change oral drug for controlling blood glucose

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maryam Zare, MS condidate	Contact	+989132275832		zare.m@ajums.ac.ir

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahvaz Jundishapoor University of Medical Sciences	Recruiting	Ahvāz	Khoozestan		Iran

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007249	Inflammation

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided