The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes

September 29, 2017 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial

The aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes Association of Iran-Babul ". Patients were randomly allocated to either the BJ group (n=23) who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no intervention. At the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fasting blood glucose>100 mg/dL (5.6 mmol /L)
  • Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg
  • Triglycerides> 150 mg/dL (1.7 mmol/L)

Exclusion Criteria:

  • taking insulin
  • smoking
  • using antioxidant supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
patients in this group were received 200 ml/d barberry juice for tow month
Other: barberry juice
No Intervention: control group
patients in this group received no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fasting blood glucose
Time Frame: 8 weeks
8 weeks
total cholesterol
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 8 weeks
8 weeks
Triglyceride
Time Frame: 8 weeks
8 weeks
LDL- cholesterol
Time Frame: 8 weeks
8 weeks
HDL- cholesterol
Time Frame: 8 weeks
8 weeks
Systolic BP
Time Frame: 8 weeks
8 weeks
Diastolic BP
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

April 16, 2017

Study Completion (Actual)

August 5, 2017

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1534

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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