The Effects of Barberry Juice Consumption in Patients Wit... | NCT03299153

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

NCT03299153

Sponsor

National Nutrition and Food Technology Institute

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

46Actual

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

barberry juice

Countries

Not provided

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 2017

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

Dec 21, 2016Actual

Primary Completion Date

Apr 16, 2017Actual

Completion Date

Aug 5, 2017Actual

First Submitted Date

Sep 27, 2017

First Submission Date that Met QC Criteria

Sep 29, 2017

First Posted Date

Oct 2, 2017Actual

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 29, 2017

Last Update Posted Date

Oct 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, National Nutrition and Food Technology Research Institute, 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)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	patients in this group were received 200 ml/d barberry juice for tow month	Other: barberry juice
control group	No Intervention	patients in this group received no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
barberry juice	Other		Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fasting blood glucose		8 weeks
total cholesterol		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
LDL- cholesterol		8 weeks
HDL- cholesterol		8 weeks
Triglyceride

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

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