Pharmacokinetic Study in Healthy VolunteersBERKI-3NCT06273241
Impact of Food Intake on Berberine Kinetics
A study testing food intake in people with Pharmacokinetic Study in Healthy Volunteers, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 (OCT-1) on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Study in Healthy Volunteers
- What is being tested?
- food intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 4 Mar 2024to 11 May 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- wildtype genotypes for CYP2D6 and organic cation transporter 1 (OCT-1)
- understands the study purpose and design
- contractually capable and provides signed informed consent form
- healthy condition or mild and/or well treated forms of allergies, asthma, hypertension and orthopedic diseases
Who cannot join
- BMI ≤18,5kg/m2 and ≥29,9 kg/m2
- only in women: known pregnancy or lactation period
- only in women: positive pregnancy test at screening or any other study visit
- anemia: Hb < 13 g/dl (8,07 mmol/l) in men or < 12 g/dl (7,45 mmol/l) in women
- elevated liver function tests (ALAT, ASAT, yGT, Bilirubin > 2xULN)
- reduced renal function (eGFRMDRD < 60ml/min/1,7m2)
Show all 9Show fewer
- currently mentally unstable
- use of recreational drugs more than twice a week
- poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medicine Greifswald, Institute of Pharmacology
Greifswald, Mecklenburg-Vorpommern, 17487
About this study
Official title: Impact of Food Intake on Berberine Kinetics - BERKI-3
The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 (OCT-1) on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to expectations, the previously observed sex difference could not be confirmed.
In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, the participants ate a meal. Shortly after meal intake, the plasma concentration curve peaked again.
Read more
BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, the investigators will also measure insulin and glucose after the meal at noon.
As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One by measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.
24 healthy volunteers with an equal ratio of man and women will be enrolled.
Read the detailed description
All enrolled participants will come under fasting conditions for 10 h to the Clinical Research Unit. Every volunteer will receive a single dose of 1000 mg berberine (two capsules) with 250 ml still water. Intake will be either in the fasting condition, or after a light caloric meal (2 toasts, butter, cheese, marmalade), or a high caloric meal (2 toasts with butter, 2 fried eggs, 2 slices of bacon, 3 hash brown and 240ml of whole milk), respectively. In between these different intakes will be at least one week. The order of fasting - light meal - heavy meal study visits will be randomized.
A total amount of 12 blood samples at defined time points (baseline; 1; 2; 3; 4; 5; 6; 7; 8; 24 h) will be taken. At each time point, blood will be collected in a tube for collecting plasma. In addition, for glucose and insulin measurements, blood samples will be obtained at 4 h, 5 h and 6 h .
Every hour until the meal at noon, participants will drink 100 ml of sparkling water to stimulate the intestinal peristalsis and promote transport of the capsule. Volunteers are asked to stay in bed for four hours after berberine intake but then are allowed to move freely in the Clinical Research Unit. After 2 h participants will be served tea or coffee and after 4 h a meal will be served.
Urine will be collected at the first 8 h after administration. The participants will stay in the Clinical Research Unit of the Institute of Pharmacology for the first 8 hours after administration.
- Being tested
- food intake
- Keywords
- berberine, food effect, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food intakeOther
A single dose of 1000 mg berberine in two capsules will be administered with 250 ml of still water in the overnight fasting condition as the control condition. The two intervention arms will test the effect of different meals on berberine kinetics. A total amount of 12 blood samples at defined time points (baseline; 1; 2; 3; 4; 5; 6; 7; 8; 24 h) will be taken. For glucose and insulin measurements, blood samples will be obtained at 4 h, 5 h and 6 h .
| Study group | Role | What they receive |
|---|---|---|
| Berberine intake in fasted condition | Placebo comparator | Intake of 1000 mg berberine in the fasted condition (intake of last meal: before 20:00 on the day before the study visit) Receives: Other: food intake |
| Berberine intake after a low caloric meal | Active comparator | Intake of 1000 mg berberine after a light caloric meal (2 toasts, butter, cheese, marmalade) Receives: Other: food intake |
| Berberine intake after a high caloric meal | Active comparator | Intake of 1000 mg berberine after a high caloric meal (2 toasts with butter, 2 fried eggs, 2 slices of bacon, 3 hash brown and 240ml of whole milk) Receives: Other: food intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berberine plasma concentration fasted vs fed
Difference of berberine plasma concentrations between the fasted and fed condition, expressed as area under the curve (AUC0-24h).
Measured: 24 hours
Secondary outcomes (1)
Berberine plasma concentrations light vs heavy meal
Difference of berberine plasma concentrations after a light and heavy meal, expressed as area under the curve (AUC0-24h).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start4 Mar 2024
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic Study in Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Engeli, MD, University Medicine Greifswald
- Investigators
- Stefan Engeli, Prof., Principal investigator, Universitätsmedizin Greifswald, Institut für Pharmakologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273241
- Sponsor's protocol ID
- IPHA-2024-009
- Acronym
- BERKI-3
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2024
- Last updated
- 24 Jan 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Food Intake on Berberine Kinetics - BERKI-3
- ClinicalTrials.gov ID
- NCT06273241
- Acronym / sponsor ID
- BERKI-3 / IPHA-2024-009
- Keywords
- berberine, food effect, pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 22 Feb 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.
The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 (OCT-1) on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to expectations, the previously observed sex difference could not be confirmed.
In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, the participants ate a meal. Shortly after meal intake, the plasma concentration curve peaked again.
BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, the investigators will also measure insulin and glucose after the meal at noon.
As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One by measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.
24 healthy volunteers with an equal ratio of man and women will be enrolled.
Detailed description
All enrolled participants will come under fasting conditions for 10 h to the Clinical Research Unit. Every volunteer will receive a single dose of 1000 mg berberine (two capsules) with 250 ml still water. Intake will be either in the fasting condition, or after a light caloric meal (2 toasts, butter, cheese, marmalade), or a high caloric meal (2 toasts with butter, 2 fried eggs, 2 slices of bacon, 3 hash brown and 240ml of whole milk), respectively. In between these different intakes will be at least one week. The order of fasting - light meal - heavy meal study visits will be randomized.
A total amount of 12 blood samples at defined time points (baseline; 1; 2; 3; 4; 5; 6; 7; 8; 24 h) will be taken. At each time point, blood will be collected in a tube for collecting plasma. In addition, for glucose and insulin measurements, blood samples will be obtained at 4 h, 5 h and 6 h .
Every hour until the meal at noon, participants will drink 100 ml of sparkling water to stimulate the intestinal peristalsis and promote transport of the capsule. Volunteers are asked to stay in bed for four hours after berberine intake but then are allowed to move freely in the Clinical Research Unit. After 2 h participants will be served tea or coffee and after 4 h a meal will be served.
Urine will be collected at the first 8 h after administration. The participants will stay in the Clinical Research Unit of the Institute of Pharmacology for the first 8 hours after administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Berberine intake in fasted condition | Placebo comparator | Other: food intakeIntake of 1000 mg berberine in the fasted condition (intake of last meal: before 20:00 on the day before the study visit) |
| Berberine intake after a low caloric meal | Active comparator | Other: food intakeIntake of 1000 mg berberine after a light caloric meal (2 toasts, butter, cheese, marmalade) |
| Berberine intake after a high caloric meal | Active comparator | Other: food intakeIntake of 1000 mg berberine after a high caloric meal (2 toasts with butter, 2 fried eggs, 2 slices of bacon, 3 hash brown and 240ml of whole milk) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- wildtype genotypes for CYP2D6 and organic cation transporter 1 (OCT-1)
- understands the study purpose and design
- contractually capable and provides signed informed consent form
- healthy condition or mild and/or well treated forms of allergies, asthma, hypertension and orthopedic diseases
Key exclusion criteria (9 listed)
- BMI ≤18,5kg/m2 and ≥29,9 kg/m2
- only in women: known pregnancy or lactation period
- only in women: positive pregnancy test at screening or any other study visit
- anemia: Hb < 13 g/dl (8,07 mmol/l) in men or < 12 g/dl (7,45 mmol/l) in women
- elevated liver function tests (ALAT, ASAT, yGT, Bilirubin > 2xULN)
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 |
|---|---|---|
| food intakeA single dose of 1000 mg berberine in two capsules will be administered with 250 ml of still water in the overnight fasting condition as the control condition. The two intervention arms will test the effect of different meals on berberine kinetics. A total amount of 12 blood samples at defined time points (baseline; 1; 2; 3; 4; 5; 6; 7; 8; 24 h) will be taken. For glucose and insulin measurements, blood samples will be obtained at 4 h, 5 h and 6 h . | Other | Berberine intake after a high caloric meal, Berberine intake after a low caloric meal, Berberine intake in fasted condition |
Primary outcome
Berberine plasma concentration fasted vs fed
Time frame: 24 hours
Difference of berberine plasma concentrations between the fasted and fed condition, expressed as area under the curve (AUC0-24h).
1 secondary outcome
Berberine plasma concentrations light vs heavy meal
Time frame: 24 hours
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 24 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Pharmacokinetic Study in Healthy Volunteers
Not yet recruitingPhase 1
Pharmacokinetics, Safety and Tolerability of Single Sequential and Multiple Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
Healthy Participants, Ulinastatin
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of KM04 Compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in Healthy Adult Female Volunteers
Healthy Female Adult Volunteers
RecruitingPhase 1
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants
Healthy Adult Participants
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
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.
Stefan Engeli, Prof. principal investigator
Universitätsmedizin Greifswald, Institut für Pharmakologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food intake in people with Pharmacokinetic Study in Healthy Volunteers, run by University Medicine Greifswald at 1 site in Germany.
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 4 inclusion and 9 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 Jan 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Berberine plasma concentration fasted vs fed (time frame: 24 hours). 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 24 Jan 2025.