Effects of Pomegranate Juice on Oxidative Stress in Patie... | NCT02559843

Studies
Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes

NCT02559843

Sponsor

National Nutrition and Food Technology Institute

Status

Completed

Last Update Posted

Sep 24, 2015Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Diabetes Type 2

Interventions

pomegranate juice
lifestyle modification

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Sep 15, 2015

First Submission Date that Met QC Criteria

Sep 23, 2015

First Posted Date

Sep 24, 2015Estimated

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

Sep 23, 2015

Last Update Posted Date

Sep 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, Faculty member, National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pomegranate juice	Experimental	200 ml pomegranate juice + lifestyle modification	Dietary Supplement: pomegranate juice
control	Active Comparator	lifestyle modification including dietary recommendations	Behavioral: lifestyle modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pomegranate juice	Dietary Supplement		pomegranate juice
lifestyle modification

Measure	Description	Time Frame
total antioxidant capacity		6 weeks

Measure	Description	Time Frame
fasting blood glucose		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 40-65 years
Body Mass Index 18.5-30
Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NNFTRI clinic		Tehran	Tehran Province	19435	Iran

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided