Clinical trial NCT06483932: Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia
Official title: Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Hypertriglyceridemia
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
name: Kashan University of Medical Sciences
First posted: 2024-07-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentration of triglycerides
timeFrame: At baseline, the fourth week and the eighth week of study
measure: Plasma concentration of high-density lipoprotein cholesterol (HDL-C)
timeFrame: At baseline, the fourth week and the eighth week of study
Secondary outcomes:
measure: Body weight
timeFrame: At baseline, the fourth week and the eighth week of study
measure: Plasma Cholesterol
timeFrame: At baseline, the fourth week and the eighth week of study
measure: Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)
timeFrame: At baseline and the eighth week of study
measure: Plasma C-reactive protein
timeFrame: At baseline and the eighth week of study
measure: Plasma Insulin
timeFrame: At baseline and the eighth week of study
measure: Blood pressure
timeFrame: At baseline, the fourth week and the eighth week of study
measure: Urinary polyphenol
timeFrame: At baseline, the fourth week and the eighth week of study
Other outcomes:
Locations:
city: Kāshān
country: Iran, Islamic Republic of
facility: Shahid Beheshty Unversity Hospital
state: Isfahan
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Javad Nasrollahzadeh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: