HyperlipidemiasNCT06483932
Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia
A study testing Dried barberry and Low-calorie diet in people with Hyperlipidemias and Hypertriglyceridemia, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemias, Hypertriglyceridemia
- What is being tested?
- Dried barberry and Low-calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- 9 Sep 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting serum triglycerides 150-499 mg/dL,
- Body mass index 25-40 kg/m2
- Age range 18-75 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia
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.
Read the 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.
- Conditions
- Hyperlipidemias, Hypertriglyceridemia
- Being tested
- Dried barberry, Low-calorie diet
- Medical subject headings
- Hyperlipidemias, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried barberryOther
Also called Berberis vulgaris
Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.
Low-calorie dietOther
Diet with 500 kcal subtracted from the daily energy requirement
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A diet with a reduced calorie intake Receives: Other: Low-calorie diet |
| Barberry | Experimental | A diet with a reduced calorie intake, coupled with the consumption of barberry Receives: Other: Dried barberry; Other: Low-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of triglycerides
The plasma triglyceride concentration 12 hours after the subjects had fasted
Measured: 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
Measured: At baseline, the fourth week and the eighth week of study
Secondary outcomes (7)
Body weight
Body wight loss (kg)
Measured: 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
Measured: 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
Measured: At baseline and the eighth week of study
Plasma C-reactive protein
The plasma CRP concentration
Measured: At baseline and the eighth week of study
Plasma Insulin
The plasma insulin concentration 12 hours after the subjects had fasted
Measured: At baseline and the eighth week of study
Blood pressure
Systolic and diastolic bliood pressure
Measured: At baseline, the fourth week and the eighth week of study
Urinary polyphenol
Total polyphenol concentration in spot urine sample
Measured: At baseline, the fourth week and the eighth week of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start9 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences, Kashan University of Medical Sciences
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University
- Investigators
- Javad Nasrollahzadeh, Ph.D, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483932
- Sponsor's protocol ID
- 43008122
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT06483932
- Acronym / sponsor ID
- 43008122
- Conditions
- Hyperlipidemias, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences, Kashan University of Medical Sciences
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Low-calorie dietA diet with a reduced calorie intake |
| Barberry | Experimental | Other: Dried barberry, Other: Low-calorie dietA diet with a reduced calorie intake, coupled with the consumption of barberry |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting serum triglycerides 150-499 mg/dL,
- Body mass index 25-40 kg/m2
- Age range 18-75 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried barberryAlso: Berberis vulgarisSubjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet. | Other | Barberry |
| Low-calorie dietDiet with 500 kcal subtracted from the daily energy requirement | Other | Barberry, Control |
Primary outcome
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
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
7 secondary outcomes
Body weight
Time frame: At baseline, the fourth week and the eighth week of study
Plasma Cholesterol
Time frame: At baseline, the fourth week and the eighth week of study
Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: At baseline and the eighth week of study
Plasma C-reactive protein
Time frame: At baseline and the eighth week of study
Plasma Insulin
Time frame: At baseline and the eighth week of study
Blood pressure
Time frame: At baseline, the fourth week and the eighth week of study
Urinary polyphenol
Time frame: At baseline, the fourth week and the eighth week of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javad Nasrollahzadeh, Ph.D principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried barberry and Low-calorie diet in people with Hyperlipidemias and Hypertriglyceridemia, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of triglycerides (time frame: At baseline, the fourth week and the eighth week of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.