Mixed DyslipidemiaPhase 3NCT02548832

Bezafibrate Plus Berberine in Mixed Dyslipidemia

A Phase 3 study testing Berberine, Bezafibrate and Berberine plus Bezafibrate in people with Mixed Dyslipidemia, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for… Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Mixed Dyslipidemia
What is being tested?: Berberine, Bezafibrate and Berberine plus Bezafibrate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteMexico
Study dates: Apr 2013to 1 Apr 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Men and women
Accomplished age 30 to 60 years
Diagnosis of mixed dyslipidemia established to meet the following criteria:
Total cholesterol > 5,17 mmol/l.
Triglycerides > 1,7 mmol/l.
BMI of 25 kg / m^2 to 39.9 kg / m^2, weight stable over the past three months, defined as a variability in the lower body weight of 5%.

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No drug treatment for lipid profile 3 months prior to baseline.
Women must ensure a non-hormonal method to avoid pregnancy during the study period.
Written information consent

Who cannot join

Removal for informed consent letter
Loss of monitoring
Presence of serious adverse event
Adherence to treatment <80%
Consumption of drugs known about lipid profile, glucose metabolism, blood pressure and body weight during the intervention period influence
Intolerance or not tolerability or hypersensitivity to the compounds used in the study

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

Official title: Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial

Currently, fibrates, such as bezafibrate, are drugs used in treating hypertriglyceridemia, besides reducing the risk of coronary disease. However, although this treatment is safe, it is not without risks; with increased prevalence of adverse effects as the dose thereof is increased or joins combination with a statin drug for the treatment of mixed dyslipidemia long term.

Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides may be useful in combination with bezafibrate in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.

Read the detailed description

The aim of this study is to evaluate the effect of berberine plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia.The investigators will conduct a double-blind randomized pilot clinical trial with parallel groups in men and women aged 30-60 years old with diagnosis of mixed dyslipidemia.

Patients will be assigned to 3 groups:

12 patients will receive berberine, 1500 mg / day
12 Patients will receive bezafibrate 400 mg / day
12 patients will receive a combination of berberine (1500 mg / day) plus bezafibrate (400 mg / day).

All participants will be determined before and after the intervention: lipid profile, total cholesterol (TC), triglycerides (TG), HDL-C, low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein (VLDL).

Also weight, Body Mass Index (BMI), waist circumference (WC), glucose, systolic blood pressure (SBP), diastolic blood pressure (DBP), creatinine (CR) uric acid (UA) and tolerability.

Statistical analysis was performed upon the sample of subjects.

Previous start the statistical analysis of the groups will proceed to verify the behavior of the distribution of the variables included by Z Kolmogorov-Smirnov goodness of fit.

The distribution of all the variables under this test is cataloged in normal or not normal, which define the type of statistical test would be performed (parametric or non-parametric). However, based on the sample size, non-parametric tests will be those considered most suitable for application.

The data obtained will be expressed and presented using measures of central tendency and dispersion for quantitative (mean and standard deviation) variables and qualitative variables are expressed as frequencies and percentages.

Conditions: Mixed Dyslipidemia
Being tested: Berberine, Bezafibrate, Berberine plus Bezafibrate
Keywords: Berberine, Bezafibrate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BerberineDrug
Berberine 1500 mg, each 24 h for 90 days
1 Berberine capsule 500 mg for breakfast.
1 Berberine capsule 500 mg for lunch.
1 Berberine capsule 500 mg for dinner.
BezafibrateDrug
Bezafibrate capsule 400 mg each 24 h for 90 days.
1 Bezafibrate capsule 200 mg for breakfast.
1 Bezafibrate capsule 200 mg for dinner.
Berberine plus BezafibrateDrug
Also called Berberine, bezafibrate
Berberine 1500 mg each 24 h for 90 days
1 Berberine capsule 500 mg for breakfast.
1 Berberine capsule 500 mg for lunch.
1 Berberine capsule 500 mg for dinner.
Bezafibrate 400 mg each 24 h for 90 days.
1 Bezafibrate capsule 200 mg for breakfast.
1 Bezafibrate capsule 200 mg for dinner.

Study groups in NCT02548832
Study group	Role	What they receive
Berberine	Experimental	Berberine 500 mg with breakfast, meal, and dinner. Receives: Drug: Berberine
Bezafibrate	Experimental	Bezafibrate 200 mg on breakfast and dinner. Receives: Drug: Bezafibrate
Berberine plus Bezafibrate	Experimental	Berberine 500 mg with breakfast, meal, and dinner, and bezafibrate 200 mg only on breakfast and dinner. Receives: Drug: Berberine plus Bezafibrate

What is being measured

The primary outcome is the main question the study is designed to answer.

Triglycerides After 90 Days
The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Measured: 90 days
Total Cholesterol After 90 Days.
The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Measured: 90 days
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Measured: 90 days
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Measured: 90 days
Very Low Density Lipoprotein After 90 Days
The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5.
Measured: 90 days

Secondary outcomes (8)

Body Weight (BW) After 90 Days
The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
Measured: 90 days
Body Mass Index (BMI) After 90 Days
The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres.
Measured: 90 days
Waist Circumference (WC) After 90 Days
The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
Measured: 90 days
Systolic Blood Pressure After 90 Days
The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.
Measured: 90 days
Diastolic Blood Pressure After 90 Days
The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.
Measured: 90 days
Fasting Serum Glucose (FSG) After 90 Days
The glucose oxidase technique (Beckman Instruments, Inc., Brea, California, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of <1.
Measured: 90 days
Uric Acid After 90 Days
The blood sample for the determination of uric acid was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Measured: 90 days
Creatinine After 90 Days
The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20131 Apr 2020

First posted14 Sep 2015 (estimated)
Study startApr 2013
Primary completion1 Apr 2020
Study completion1 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mixed DyslipidemiaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548832
Sponsor's protocol ID: EABYBL
Status last verified: Jan 2022
First submitted: 10 Sep 2015
Last updated: 24 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingObservational study
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemiia, Mixed Dyslipidemia
Not yet recruitingPhase 3
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Coronary Atherosclerosis, Mixed Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia

All Mixed Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial
ClinicalTrials.gov ID: NCT02548832
Acronym / sponsor ID: EABYBL
Conditions: Mixed Dyslipidemia
Keywords: Berberine, Bezafibrate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Apr 2013
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 24 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients will be assigned to 3 groups:

12 patients will receive berberine, 1500 mg / day
12 Patients will receive bezafibrate 400 mg / day
12 patients will receive a combination of berberine (1500 mg / day) plus bezafibrate (400 mg / day).

Also weight, Body Mass Index (BMI), waist circumference (WC), glucose, systolic blood pressure (SBP), diastolic blood pressure (DBP), creatinine (CR) uric acid (UA) and tolerability.

Statistical analysis was performed upon the sample of subjects.

Previous start the statistical analysis of the groups will proceed to verify the behavior of the distribution of the variables included by Z Kolmogorov-Smirnov goodness of fit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Berberine	Experimental	Drug: BerberineBerberine 500 mg with breakfast, meal, and dinner.
Bezafibrate	Experimental	Drug: BezafibrateBezafibrate 200 mg on breakfast and dinner.
Berberine plus Bezafibrate	Experimental	Drug: Berberine plus BezafibrateBerberine 500 mg with breakfast, meal, and dinner, and bezafibrate 200 mg only on breakfast and dinner.

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Men and women
Accomplished age 30 to 60 years
Diagnosis of mixed dyslipidemia established to meet the following criteria:
Total cholesterol > 5,17 mmol/l.
Triglycerides > 1,7 mmol/l.

Key exclusion criteria (6 listed)

Removal for informed consent letter
Loss of monitoring
Presence of serious adverse event
Adherence to treatment <80%
Consumption of drugs known about lipid profile, glucose metabolism, blood pressure and body weight during the intervention period influence

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
BerberineBerberine 1500 mg, each 24 h for 90 days 1 Berberine capsule 500 mg for breakfast. 1 Berberine capsule 500 mg for lunch. 1 Berberine capsule 500 mg for dinner.	Drug	Berberine
BezafibrateBezafibrate capsule 400 mg each 24 h for 90 days. 1 Bezafibrate capsule 200 mg for breakfast. 1 Bezafibrate capsule 200 mg for dinner.	Drug	Bezafibrate
Berberine plus BezafibrateAlso: Berberine, bezafibrateBerberine 1500 mg each 24 h for 90 days 1 Berberine capsule 500 mg for breakfast. 1 Berberine capsule 500 mg for lunch. 1 Berberine capsule 500 mg for dinner. Bezafibrate 400 mg each 24 h for 90 days. 1 Bezafibrate capsule 200 mg for breakfast. 1 Bezafibrate capsule 200 mg for dinner.	Drug	Berberine plus Bezafibrate

Primary outcome

Triglycerides After 90 Days
Time frame: 90 days
The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Total Cholesterol After 90 Days.
Time frame: 90 days
The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
Time frame: 90 days
The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
Time frame: 90 days
The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method.
Very Low Density Lipoprotein After 90 Days
Time frame: 90 days
The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5.

8 secondary outcomes

Body Weight (BW) After 90 Days
Time frame: 90 days
Body Mass Index (BMI) After 90 Days
Time frame: 90 days
Waist Circumference (WC) After 90 Days
Time frame: 90 days
Systolic Blood Pressure After 90 Days
Time frame: 90 days
Diastolic Blood Pressure After 90 Days
Time frame: 90 days
Fasting Serum Glucose (FSG) After 90 Days
Time frame: 90 days
Uric Acid After 90 Days
Time frame: 90 days
Creatinine After 90 Days
Time frame: 90 days

Results and safety

Results posted to the registry on 24 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Berberine	12	10
Bezafibrate	12	10
Berberine Plus Bezafibrate	12	10

Primary outcome: Triglycerides After 90 Days

Time frame: 90 days. Mean (Standard Deviation). Unit: mmol/L

Measure	Berberine n = 10	Bezafibrate n = 10	Berberine Plus Bezafibrate n = 10
Value	2.3 (0.9)	1.1 (0.4)	1.3 (0.7)

Primary outcome: Total Cholesterol After 90 Days.

Time frame: 90 days. Mean (Standard Deviation). Unit: mM

Measure	Berberine n = 10	Bezafibrate n = 10	Berberine Plus Bezafibrate n = 10
Value	5.3 (0.5)	5.8 (0.8)	4.6 (1.2)

Primary outcome: Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days

Time frame: 90 days. Mean (Standard Deviation). Unit: mM

Measure	Berberine n = 10	Bezafibrate n = 10	Berberine Plus Bezafibrate n = 10
Value	2.8 (0.8)	2.4 (0.6)	2.2 (1.3)

Primary outcome: High Density Lipoprotein Cholesterol (HDL-c) After 90 Days

Time frame: 90 days. Mean (Standard Deviation). Unit: mM

Measure	Berberine n = 10	Bezafibrate n = 10	Berberine Plus Bezafibrate n = 10
Value	1.5 (0.3)	2.0 (0.3)	1.8 (0.5)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: adverse events were collected throughout the 90 days of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Berberine	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Bezafibrate	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Berberine Plus Bezafibrate	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Limitations and caveats (from the sponsor): Time of intervention and the sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Mixed Dyslipidemia

RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingObservational study
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemiia, Mixed Dyslipidemia
Not yet recruitingPhase 3
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Coronary Atherosclerosis, Mixed Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia

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.

Esperanza Martínez-Abundis principal investigator

INTEC, CUCS, University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Berberine, Bezafibrate and Berberine plus Bezafibrate in people with Mixed Dyslipidemia, run by University of Guadalajara at 1 site in Mexico.

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 9 inclusion and 6 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 24 Feb 2023. 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 Mexico. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Triglycerides After 90 Days (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548832.

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 24 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.