Hyperlipidemias, Hypertriglyceridemia
Conditions
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.
Interventions
OTHERDried barberry
Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.
OTHERLow-calorie diet
Diet with 500 kcal subtracted from the daily energy requirement
Sponsors
Shahid Beheshti University of Medical Sciences
Kashan University of Medical Sciences
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of triglycerides | At baseline, the fourth week and the eighth week of study | The plasma triglyceride concentration 12 hours after the subjects had fasted |
| Plasma concentration of high-density lipoprotein cholesterol (HDL-C) | At baseline, the fourth week and the eighth week of study | The plasma HDL-C concentration 12 hours after the subjects had fasted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | At baseline, the fourth week and the eighth week of study | Body wight loss (kg) |
| Plasma Cholesterol | 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 |
| Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) | At baseline and the eighth week of study | The plasma PCSK9 concentration 12 hours after the subjects had fasted |
| Plasma C-reactive protein | At baseline and the eighth week of study | The plasma CRP concentration |
| Plasma Insulin | At baseline and the eighth week of study | The plasma insulin concentration 12 hours after the subjects had fasted |
| Blood pressure | At baseline, the fourth week and the eighth week of study | Systolic and diastolic bliood pressure |
| Urinary polyphenol | At baseline, the fourth week and the eighth week of study | Total polyphenol concentration in spot urine sample |
Countries
Iran
Outcome results
None listed