Shahid Beheshty Unversity Hospital
Kāshān, Isfahan, Iran
NCT Number: NCT06483932
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Kāshān, Isfahan, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.
Other names: Berberis vulgaris
Diet with 500 kcal subtracted from the daily energy requirement
Time frame: At baseline, the fourth week and the eighth week of study
The plasma triglyceride concentration 12 hours after the subjects had fasted
Time frame: At baseline, the fourth week and the eighth week of study
The plasma HDL-C concentration 12 hours after the subjects had fasted
Time frame: At baseline, the fourth week and the eighth week of study
Body wight loss (kg)
Time frame: 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
Time frame: At baseline and the eighth week of study
The plasma PCSK9 concentration 12 hours after the subjects had fasted
Time frame: At baseline and the eighth week of study
The plasma CRP concentration
Time frame: At baseline and the eighth week of study
The plasma insulin concentration 12 hours after the subjects had fasted
Time frame: At baseline, the fourth week and the eighth week of study
Systolic and diastolic bliood pressure
Time frame: At baseline, the fourth week and the eighth week of study
Total polyphenol concentration in spot urine sample
Shahid Beheshti University
Other
Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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