Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia

Not Applicable

Completed

• Conditions: Hyperlipidemias; Hypertriglyceridemia
• Interventions: Other: Dried barberry; Other: Low-calorie diet

• Registration Number: NCT06483932
• Lead Sponsor: Shahid Beheshti University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-09-09
• Status Verified: 2024-12
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barberry	Low-calorie diet	A diet with a reduced calorie intake, coupled with the consumption of barberry
Control	Low-calorie diet	A diet with a reduced calorie intake
Barberry	Dried barberry	A diet with a reduced calorie intake, coupled with the consumption of barberry

Primary Outcome Measures

Name	Time	Method
Plasma concentration of high-density lipoprotein cholesterol (HDL-C)	At baseline, the fourth week and the eighth week of study	The plasma HDL-C concentration 12 hours after the subjects had fasted
Plasma concentration of triglycerides	At baseline, the fourth week and the eighth week of study	The plasma triglyceride concentration 12 hours after the subjects had fasted

Secondary Outcome Measures

Name	Time	Method
Body weight	At baseline, the fourth week and the eighth week of study	Body wight loss (kg)
Plasma Insulin	At baseline and the eighth week of study	The plasma insulin concentration 12 hours after the subjects had fasted
Blood pressure	At baseline, the fourth week and the eighth week of study	Systolic and diastolic bliood pressure
Plasma Cholesterol	At baseline, the fourth week and the eighth week of study	The plasma total cholesterol and LDL-C concentrations 12 hours after the subjects had fasted
Plasma C-reactive protein	At baseline and the eighth week of study	The plasma CRP concentration
Urinary polyphenol	At baseline, the fourth week and the eighth week of study	Total polyphenol concentration in spot urine sample
Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)	At baseline and the eighth week of study	The plasma PCSK9 concentration 12 hours after the subjects had fasted

Trial Locations

Locations (1)

Shahid Beheshty Unversity Hospital; 🇮🇷 Kāshān, Isfahan, Iran, Islamic Republic of