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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
barberry juice
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    control group

    Arm Description

    patients in this group were received 200 ml/d barberry juice for tow month

    patients in this group received no intervention

    Outcomes

    Primary Outcome Measures

    fasting blood glucose
    total cholesterol

    Secondary Outcome Measures

    LDL- cholesterol
    HDL- cholesterol
    Triglyceride
    HbA1c
    Systolic BP
    Diastolic BP

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    September 29, 2017
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03299153
    Brief Title
    The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 21, 2016 (Actual)
    Primary Completion Date
    April 16, 2017 (Actual)
    Study Completion Date
    August 5, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    patients in this group were received 200 ml/d barberry juice for tow month
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    patients in this group received no intervention
    Intervention Type
    Other
    Intervention Name(s)
    barberry juice
    Primary Outcome Measure Information:
    Title
    fasting blood glucose
    Time Frame
    8 weeks
    Title
    total cholesterol
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    LDL- cholesterol
    Time Frame
    8 weeks
    Title
    HDL- cholesterol
    Time Frame
    8 weeks
    Title
    Triglyceride
    Time Frame
    8 weeks
    Title
    HbA1c
    Time Frame
    8 weeks
    Title
    Systolic BP
    Time Frame
    8 weeks
    Title
    Diastolic BP
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

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