Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia

Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias; Hypertriglyceridemia
• Intervention / Treatment: Other: Low-calorie diet; Other: Dried barberry

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan
    • Kāshān, Isfahan, Iran, Islamic Republic of
      • Shahid Beheshty Unversity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; A diet with a reduced calorie intake	Other: Low-calorie diet; Diet with 500 kcal subtracted from the daily energy requirement
Experimental: Barberry; A diet with a reduced calorie intake, coupled with the consumption of barberry	Other: Low-calorie diet; Diet with 500 kcal subtracted from the daily energy requirement; Other: Dried barberry; Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.; Other Names: Berberis vulgaris

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Collaborators: Shahid Beheshti University of Medical Sciences; Kashan University of Medical Sciences
• Investigators: Principal Investigator: Javad Nasrollahzadeh, Ph.D, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 3, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hypertriglyceridemia; Hyperlipidemias
• Other Study ID Numbers: 43008122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No