Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shahid Beheshti University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Plasma concentration of high-density lipoprotein cholesterol (HDL-C)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
A diet with a reduced calorie intake
Intervention: Low-calorie diet (Other)
Barberry
A diet with a reduced calorie intake, coupled with the consumption of barberry
Intervention: Dried barberry (Other)
Barberry
A diet with a reduced calorie intake, coupled with the consumption of barberry
Intervention: Low-calorie diet (Other)
Outcomes
Primary Outcomes
Plasma concentration of high-density lipoprotein cholesterol (HDL-C)
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
Plasma concentration of triglycerides
Time Frame: At baseline, the fourth week and the eighth week of study
The plasma triglyceride concentration 12 hours after the subjects had fasted
Secondary Outcomes
- Body weight(At baseline, the fourth week and the eighth week of study)
- Plasma Insulin(At baseline and the eighth week of study)
- Blood pressure(At baseline, the fourth week and the eighth week of study)
- Plasma Cholesterol(At baseline, the fourth week and the eighth week of study)
- Plasma C-reactive protein(At baseline and the eighth week of study)
- Urinary polyphenol(At baseline, the fourth week and the eighth week of study)
- Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)(At baseline and the eighth week of study)
Investigators
Javad Nasrollahzadeh
Associate Professor
Shahid Beheshti University