An interventional study of Dried barberry and Low-calorie diet in Hyperlipidemias and Hypertriglyceridemia, sponsored by Shahid Beheshti University. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Prevention
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.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 56 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Compared within Hypertriglyceridemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperlipidemias. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A diet with a reduced calorie intake
Other: Low-calorie diet
A diet with a reduced calorie intake, coupled with the consumption of barberry
Other: Dried barberry · Other: Low-calorie diet
Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.
Also known as: Berberis vulgaris
Diet with 500 kcal subtracted from the daily energy requirement
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
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University