Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Gamma-cyclodextrin on the Bioavailability of Berberine

NCT04918667

Drug Absorption

NOT_YET_RECRUITING PHASE1

Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease

NCT05988099

Hypertension Hypercholesterolemia

COMPLETED NA

Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients

NCT01680211

Prediabetes Hyperlipidemia

COMPLETED NA

A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia

NCT06323252

Hypertriglyceridemia

NOT_YET_RECRUITING NA

The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers

NCT04767230

Coronary Artery Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemias Hypertriglyceridemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

A diet with a reduced calorie intake

Group Type ACTIVE_COMPARATOR

Low-calorie diet

Intervention Type OTHER

Diet with 500 kcal subtracted from the daily energy requirement

Barberry

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

Group Type EXPERIMENTAL

Dried barberry

Intervention Type OTHER

Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.

Low-calorie diet

Intervention Type OTHER

Diet with 500 kcal subtracted from the daily energy requirement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dried barberry

Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.

Intervention Type OTHER

Low-calorie diet

Diet with 500 kcal subtracted from the daily energy requirement

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Berberis vulgaris

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No