NCT02559843

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

September 15, 2015

Last Update Submit

September 23, 2015

Conditions

Diabetes Type 2

Keywords

pomegranatediabetesoxidative stress

Outcome Measures

Primary Outcomes (1)

  • total antioxidant capacity

    6 weeks

Secondary Outcomes (1)

  • fasting blood glucose

    6 weeks

Study Arms (2)

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

pomegranate juiceDIETARY_SUPPLEMENT
pomegranate juice
lifestyle modificationBEHAVIORAL
control

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NNFTRI clinic

Tehran, Tehran Province, 19435, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 24, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

IR(1)