Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia

Shahid Beheshti University

Status: Completed

Conditions: Hyperlipidemias; Hypertriglyceridemia

Treatments: Other: Dried barberry; Other: Low-calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06483932

43008122

Details and patient eligibility

About

Barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. Barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. Based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. The present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.

Full description

This study is an open-label, randomized, controlled clinical trial and will recruit those who are willing to participate and meet the inclusion criteria. Inclusion criteria are fasting serum triglycerides 150-499 mg/dL, body mass index 25-40 kg/m2, age range 18-75 years. Exclusion criteria are regular use of drugs of the fibrate family, regular use of fish oil supplements or omega-3 supplements or flax seed or chia seed, treatment with glucocorticoids, end-stage renal disease. Subjects who agree to participate in the study will be randomly assigned to one of two study groups. All patients in both groups will be prescribed a low-calorie diet. In the first group, 10 grams of powdered seedless barberry will be consumed daily in addition to the low-calorie diet. The second group (control group) will continue with the low calorie diet. The study will last 8 weeks. Patients are asked to refrain from using over-the-counter herbal medicines and dietary supplements during the study. A baseline fasting blood sample, blood pressure measurements, and anthropometric indices will be obtained. Subsequent assessments will be made at four-week and eight-week intervals.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting serum triglycerides 150-499 mg/dL,
• Body mass index 25-40 kg/m2
• Age range 18-75 years

Exclusion criteria

• Regular use of drugs of the fibrate family, fish oil supplements or omega-3 supplements
• Regular consumption of flax seed or chia seed
• Treatment with glucocorticoids
• End-stage renal disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Control

Active Comparator group

Description:

A diet with a reduced calorie intake

Treatment:

Other: Low-calorie diet

Barberry

Experimental group

Description:

A diet with a reduced calorie intake, coupled with the consumption of barberry

Treatment:

Other: Low-calorie diet

Other: Dried barberry