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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03299153
Other study ID # 1534
Secondary ID
Status Completed
Phase Phase 4
First received September 27, 2017
Last updated September 29, 2017
Start date December 21, 2016
Est. completion date August 5, 2017

Study information

Verified date September 2017
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date August 5, 2017
Est. primary completion date April 16, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
barberry juice


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Outcome

Type Measure Description Time frame Safety issue
Primary fasting blood glucose 8 weeks
Primary total cholesterol 8 weeks
Secondary LDL- cholesterol 8 weeks
Secondary HDL- cholesterol 8 weeks
Secondary Triglyceride 8 weeks
Secondary HbA1c 8 weeks
Secondary Systolic BP 8 weeks
Secondary Diastolic BP 8 weeks
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