PharmacokineticsNCT05370261
Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels
A study testing Berberine LipoMicel and Regular Berberine hard-gels in people with Pharmacokinetics, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Berberine LipoMicel and Regular Berberine hard-gels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 4 May 2022
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-65
- healthy, good physical condition
Who cannot join
- Pregnancy or breast-feeding
- Gastrointestinal conditions
- Acute or chronic liver disease
- Acute or chronic kidney disease
- Acute or chronic cardiovascular disease
- Hematological disease
Show all 14Show fewer
- Diabetes
- Allergy or Intolerance to gluten
- Allergy or Intolerance to Berberine
- Use of any form of nicotine or tobacco
- Alcohol and substance abuse history
- Use of medications (e.g., blood sugar-lowering agents, or statins)
- Use of Berberine supplements
- Participation in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels
The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.
As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.
- Conditions
- Pharmacokinetics
- Being tested
- Berberine LipoMicel, Regular Berberine hard-gels
- Keywords
- Bioavailability, Berberine, LipoMicel, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine LipoMicelDietary supplement
Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine
Regular Berberine hard-gelsDietary supplement
Total dose of 500 mg of berberine
| Study group | Role | What they receive |
|---|---|---|
| Berberine LipoMicel soft-gel | Experimental | Each participant receives their treatment of Berberine LipoMicel soft-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.
Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing.
Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used.
Adverse events are recorded throughout the study by direct questioning. Receives: Dietary Supplement: Berberine LipoMicel |
| Regular Berberine hard-gel | Experimental | Each participant receives their treatment of regular Berberine hard-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.
Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing.
Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used.
Adverse events are recorded throughout the study by direct questioning. Receives: Dietary Supplement: Regular Berberine hard-gels |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC: the area under the concentration-time curve
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Area under the plasma concentration versus time curve (AUC) with that of with free/regular berberine (hydrochloride).
Measured: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Cmax: maximum plasma concentration
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Peak Plasma Concentration (Cmax) with that of with free/regular berberine (hydrochloride).
Measured: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Tmax: the time point of maximum plasma concentration
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the time point of maximum plasma concentration (Tmax) with that of with free/regular berberine (hydrochloride).
Measured: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Secondary outcomes (2)
Effects on Blood sugar levels
To evaluate the immediate or short-term effects of orally ingested Berberine on blood sugar levels in healthy volunteers by using a glucose tolerance test (OGTT).
Measured: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
Changes in Blood sugar concentrations
To evaluate changes in blood sugar concentrations of orally ingested Berberine in healthy volunteers by using a portable glucometer.
Measured: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Feb 2022
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Factors Group of Nutritional Companies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370261
- Sponsor's protocol ID
- 2021-08-004
- Status last verified
- Feb 2023
- First submitted
- 4 May 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solnier J, Zhang Y, Kuo YC, Du M, Roh K, Gahler R, Wood S, Chang C. Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers. Pharmaceutics. 2023 Nov 1;15(11):2567. doi: 10.3390/pharmaceutics15112567.
PubMed 38004546
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels
- ClinicalTrials.gov ID
- NCT05370261
- Acronym / sponsor ID
- 2021-08-004
- Conditions
- Pharmacokinetics
- Keywords
- Bioavailability, Berberine, LipoMicel, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Factors Group of Nutritional Companies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 11 May 2022 (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 primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.
As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine LipoMicel soft-gel | Experimental | Dietary Supplement: Berberine LipoMicelEach participant receives their treatment of Berberine LipoMicel soft-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning. |
| Regular Berberine hard-gel | Experimental | Dietary Supplement: Regular Berberine hard-gelsEach participant receives their treatment of regular Berberine hard-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21-65
- healthy, good physical condition
Key exclusion criteria (14 listed)
- Pregnancy or breast-feeding
- Gastrointestinal conditions
- Acute or chronic liver disease
- Acute or chronic kidney disease
- Acute or chronic cardiovascular 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 |
|---|---|---|
| Berberine LipoMicelBerberine LipoMicel® soft-gels. Total dose of 500 mg of berberine | Dietary supplement | Berberine LipoMicel soft-gel |
| Regular Berberine hard-gelsTotal dose of 500 mg of berberine | Dietary supplement | Regular Berberine hard-gel |
Primary outcome
AUC: the area under the concentration-time curve
Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Area under the plasma concentration versus time curve (AUC) with that of with free/regular berberine (hydrochloride).
Cmax: maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Peak Plasma Concentration (Cmax) with that of with free/regular berberine (hydrochloride).
Tmax: the time point of maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the time point of maximum plasma concentration (Tmax) with that of with free/regular berberine (hydrochloride).
2 secondary outcomes
Effects on Blood sugar levels
Time frame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
Changes in Blood sugar concentrations
Time frame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
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 13 Feb 2023.
- Derived from this study: PubMed 38004546Solnier J, Zhang Y, Kuo YC, Du M, Roh K, Gahler R, Wood S, Chang C. Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers. Pharmaceutics. 2023 Nov 1;15(11):2567. doi: 10.3390/pharmaceutics15112567.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine LipoMicel and Regular Berberine hard-gels in people with Pharmacokinetics, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
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 2 inclusion and 14 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 13 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 Canada. 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?
AUC: the area under the concentration-time curve (time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)). The study lists 3 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 NCT05370261, which also lists 1 linked publication.
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 13 Feb 2023.