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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
56
Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.
Diet with 500 kcal subtracted from the daily energy requirement
Shahid Beheshty Unversity Hospital
Kāshān, Isfahan, Iran
Plasma concentration of triglycerides
The plasma triglyceride concentration 12 hours after the subjects had fasted
Time frame: 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
Time frame: At baseline, the fourth week and the eighth week of study
Body weight
Body wight loss (kg)
Time frame: 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
Time frame: 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
Time frame: At baseline and the eighth week of study
Plasma C-reactive protein
The plasma CRP concentration
Time frame: At baseline and the eighth week of study
Plasma Insulin
The plasma insulin concentration 12 hours after the subjects had fasted
Time frame: At baseline and the eighth week of study
Blood pressure
Systolic and diastolic bliood pressure
Time frame: At baseline, the fourth week and the eighth week of study
Urinary polyphenol
Total polyphenol concentration in spot urine sample
Time frame: At baseline, the fourth week and the eighth week of study
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