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CompletedNCT03299153Updated Oct 2, 2017

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

A Phase 4 interventional study of barberry juice in Type 2 Diabetes, sponsored by National Nutrition and Food Technology Institute. Completed. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by National Nutrition and Food Technology Institute · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • taking insulin
  • smoking
  • using antioxidant supplements
04

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • 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

Interventions

  • Otherbarberry juice
05

What researchers measure

Primary outcomes

  1. fasting blood glucose

    Time frame: 8 weeks

  2. total cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. LDL- cholesterol

    Time frame: 8 weeks

  2. HDL- cholesterol

    Time frame: 8 weeks

  3. Triglyceride

    Time frame: 8 weeks

  4. HbA1c

    Time frame: 8 weeks

  5. Systolic BP

    Time frame: 8 weeks

  6. Diastolic BP

    Time frame: 8 weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03299153
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (National Nutrition and Food Technology Research Institute, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Oct 2, 2017
Start date
Dec 21, 2016
Primary completion
Apr 16, 2017
Completion
Aug 5, 2017
Last update
Oct 2, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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