NCT03299153

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4 type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

September 27, 2017

Last Update Submit

September 29, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • fasting blood glucose

    8 weeks

  • total cholesterol

    8 weeks

Secondary Outcomes (6)

  • LDL- cholesterol

    8 weeks

  • HDL- cholesterol

    8 weeks

  • Triglyceride

    8 weeks

  • HbA1c

    8 weeks

  • Systolic BP

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

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

barberry juiceOTHER
Intervention group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • taking insulin
  • smoking
  • using antioxidant supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Nutrition and Food Technology Research Institute

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

December 21, 2016

Primary Completion

April 16, 2017

Study Completion

August 5, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09