BERBERINE SUPPLEMENTATIONS (Berberine)

November 6, 2026 updated by: Emine Dincer

EFFECTS OF BARBERRY (BERBERIS VULGARIS) SUPPLEMENTATIONS ON ANTIOXIDANT AND OKSIDANT CAPASITY IN HEALTHY ADULTS

This randomized, placebo-controlled interventional study aims to evaluate the effects of 60 days of supplementation with a liposomal Berberis vulgaris-based product on antioxidant status, selected biochemical parameters, body weight, body mass index (BMI), and body composition in healthy adult volunteers. The planned total enrollment is 40 participants. The intervention group will receive one 200 mg capsule daily for 60 days, subject to confirmation of the product's composition and labeling. The comparator group will receive a placebo according to the approved study protocol. Total antioxidant capacity (TAC), total oxidant status (TOS), and other prespecified outcomes will be assessed using the methods and time points defined in the protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

At baseline, participants who meet the inclusion and exclusion criteria and provide written informed consent will undergo anthropometric measurements, including body weight, height, and body composition, at the Healthy Nutrition Counseling Unit of the Faculty of Health Sciences, Sivas Cumhuriyet University. Medical history and demographic information will also be collected using a personal information form. Blood samples will be collected at the Biochemistry Laboratory of Sivas Cumhuriyet University Hospital to assess routine biochemical parameters, including glucose, insulin, renal and liver function markers, lipid profile, electrolytes, and uric acid. Blood results will be evaluated by a study physician. During the 60-day supplementation period, participants will be contacted by telephone every 15 days. Dietary intake will be assessed using 24-hour dietary recalls, and appetite status will be evaluated using the Simplified Nutrition and Appetite Questionnaire. Adherence to the intervention will be monitored through these calls and verified at the end of the study by checking the returned supplement packages and unused capsules. At baseline and at the end of the study, blood samples will also be analyzed for total antioxidant capacity (TAC), total oxidant status (TOS), paraoxonase-1 (PON1), and arylesterase (ARE) activities. Serum samples will be separated by centrifugation and stored at -80°C until analysis. TAC and TOS will be assessed as the primary outcome measures, while PON1 and ARE activities will provide additional information on enzymatic antioxidant defense. These measurements will enable a comprehensive evaluation of the effects of Berberis vulgaris supplementation on oxidative balance and antioxidant defense.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18-65 years.
  • Individuals with a body mass index (BMI) between 18,5 and 29,99 kg/m².
  • Individuals who voluntarily agree to participate in the study.
  • Individuals with no known medication sensitivities.
  • Individuals with no known food allergies.
  • Individuals who do not use medications that may affect appetite, body weight, or related parameters.
  • Individuals who do not use any dietary supplements.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Individuals who smoke.
  • Individuals with any medical condition that may affect the study outcomes, including diabetes mellitus, chronic obstructive pulmonary disease (COPD), and cardiovascular diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental

Lipozomal Berberis Vulgaris Supplementation. Participants will receive one capsule daily for 60 days. The stated capsule strength is 200 mg. The amount of Berberis vulgaris extract and/or berberine per capsule, product composition, and route of administration must be confirmed from the product documentation.
Dietary supplement: Liposomal Berberis vulgaris supplementation.

Participants will receive one capsule daily for 60 days. The stated capsule strength is 200 mg. The amount of Berberis vulgaris extract and/or berberine per capsule, product composition, and route of administration must be confirmed from the product documentation.
Placebo Comparator: Placebo

Placebo Supplementation. Participants will receive a placebo according to the approved study protocol for 60 days. The dosage form, administration schedule, and matching characteristics will be specified based on the protocol.
Other: Plasebo supplementation

Participants will receive a placebo according to the approved study protocol for 60 days. The dosage form, administration schedule, and matching characteristics will be specified based on the protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Total Antioxidant Capacity (TAC)
Time Frame: Baseline and Day 61

Change in total antioxidant capacity from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits.
Baseline and Day 61
Change in Total Oxidant Status (TOS)
Time Frame: Baseline and Day 61

Change in total oxidant status from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits.
Baseline and Day 61
Change in Body Weight
Time Frame: Baseline and Day 61

Change in body weight from baseline to the end of the intervention, measured in kilograms.
Baseline and Day 61
Change in Body Mass Index (BMI)
Time Frame: Baseline and Day 61

Change in body mass index from baseline to the end of the intervention, weight and height will be combined to report BMI in kg/m^2).
Baseline and Day 61
Change in Body Composition
Time Frame: Baseline and Day 61

Change from baseline in the prespecified body composition parameters assessed using TANITA MC 780MA.
Baseline and Day 61
Change in Biochemical Parameters
Time Frame: Baseline and Day 61

Change from baseline to the end of the intervention in each prespecified biochemical parameter.
Baseline and Day 61

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in paraoksonaz-1 (PON1)
Time Frame: Baseline and Day 61.

Change in paraoksonaz-1 (PON1) from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits.
Baseline and Day 61.
Change in arilesteraz (ARE)
Time Frame: Baseline and Day 61.

Change in arilesteraz (ARE) from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits.
Baseline and Day 61.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emine Dincer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cumhuriyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBF-2026-125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available due to institutional data privacy regulations and conditions of the informed consent form signed by the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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