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| Name | Class |
|---|---|
| Shahid Beheshti University of Medical Sciences | OTHER |
| Kashan University of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | A diet with a reduced calorie intake |
|
| Barberry | Experimental | A diet with a reduced calorie intake, coupled with the consumption of barberry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dried barberry | Other | Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of triglycerides | The plasma triglyceride concentration 12 hours after the subjects had fasted | 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 | At baseline, the fourth week and the eighth week of study |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body wight loss (kg) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javad Nasrollahzadeh, Ph.D | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Beheshty Unversity Hospital | Kāshān | Isfahan | Iran |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Low-calorie diet | Other | Diet with 500 kcal subtracted from the daily energy requirement |
|
| 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 | At baseline and the eighth week of study |
| Plasma C-reactive protein | The plasma CRP concentration | At baseline and the eighth week of study |
| Plasma Insulin | The plasma insulin concentration 12 hours after the subjects had fasted | At baseline and the eighth week of study |
| Blood pressure | Systolic and diastolic bliood pressure | At baseline, the fourth week and the eighth week of study |
| Urinary polyphenol | Total polyphenol concentration in spot urine sample | At baseline, the fourth week and the eighth week of study |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |