SafetyBerberine SafeNCT06732908
Safety Profile of a New Berberine Formulation with Improved Bioavailability
A study testing LipoMicel Berberine in people with Safety, run by Isura at 1 site in Canada.
Trial summary
This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is: Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- LipoMicel Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2024to 31 Oct 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men or women between 21-65 years of age.
- Completed an online health questionnaire on their medical history
- A voluntarily signed informed consent form.
Who cannot join
- Use of anti-inflammatory or non-steroidal anti-inflammatory medication
- Presence of cardiovascular disease and/or other acute or chronic diseases (e.g., liver, kidney or gastrointestinal diseases).
- Use of cannabis, nicotine or tobacco
- Drinking of excess alcohol (>20 g/day)
- Those who are or plan to become pregnant
- Use of antioxidant supplements
- Use of cholesterol-lowering agents
- Participation in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Safety and Tolerability of LipoMicel Berberine
This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is:
Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well tolerated in healthy individuals?
Participants will:
- Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days.
- Return to study site weekly for blood tests.
- Keep a diary of their symptoms (collection of adverse events).
- Conditions
- Safety
- Being tested
- LipoMicel Berberine, Placebo
- Keywords
- berberine, LipoMicel, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoMicel BerberineDietary supplement
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
PlaceboOther
microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Berberine LipoMicel | Active comparator | 1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days. Receives: Dietary Supplement: LipoMicel Berberine |
| Placebo | Placebo comparator | Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of LipoMicel Berberine - ALT
To evaluate changes in liver function based on ALT.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of Lipomicel Berberine - AST
To evaluate changes in liver function based on AST.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Bilirubin
To evaluate changes in liver function based on bilirubin.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Serum creatinine
To evaluate changes in kidney function based on serum creatinine.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Glomerular filtration rate (GFR)
To evaluate changes in kidney function based on GFR.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Fasting blood glucose
To evaluate changes in blood glucose levels based on fasting blood glucose.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Total cholesterol (TC)
To evaluate changes in lipid profile based on TC.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol
To evaluate changes in lipid profile based on LDL.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - High-density lipoprotein (HDL) cholesterol
To evaluate changes in lipid profile based on HDL.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Triglycerides (TG)
To evaluate changes in lipid profile based on TG.
Measured: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Secondary outcomes (11)
Tolerability of Treatment: Bloating
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Constipation
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Diarrhea
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Heartburn
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: cramps
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: knotted feeling in abdomen
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Rash
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Nausea
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Dizziness
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Blurred vision
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Other (unrelated to treatment)
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
Measured: From enrollment to the end of treatment at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start27 May 2024
- Primary completion27 Aug 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, PhD, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732908
- Sponsor's protocol ID
- 2022-11-002
- Acronym
- Berberine Safe
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 13 Dec 2024
- 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Tolerability of LipoMicel Berberine
- ClinicalTrials.gov ID
- NCT06732908
- Acronym / sponsor ID
- Berberine Safe / 2022-11-002
- Conditions
- Safety
- Keywords
- berberine, LipoMicel, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- IsuraUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 13 Dec 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.
This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is:
Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well tolerated in healthy individuals?
Participants will:
- Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days.
- Return to study site weekly for blood tests.
- Keep a diary of their symptoms (collection of adverse events).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine LipoMicel | Active comparator | Dietary Supplement: LipoMicel Berberine1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men or women between 21-65 years of age.
- Completed an online health questionnaire on their medical history
- A voluntarily signed informed consent form.
Key exclusion criteria (8 listed)
- Use of anti-inflammatory or non-steroidal anti-inflammatory medication
- Presence of cardiovascular disease and/or other acute or chronic diseases (e.g., liver, kidney or gastrointestinal diseases).
- Use of cannabis, nicotine or tobacco
- Drinking of excess alcohol (>20 g/day)
- Those who are or plan to become pregnant
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 |
|---|---|---|
| LipoMicel BerberineBerberine powder in a LipoMicel matrix encapsulated in soft gel. | Dietary supplement | Berberine LipoMicel |
| Placebomicrocrystalline cellulose | Other | Placebo |
Primary outcome
Safety of LipoMicel Berberine - ALT
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on ALT.
Safety of Lipomicel Berberine - AST
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on AST.
Safety of LipoMicel Berberine - Bilirubin
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on bilirubin.
Safety of LipoMicel Berberine - Serum creatinine
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in kidney function based on serum creatinine.
Safety of LipoMicel Berberine - Glomerular filtration rate (GFR)
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in kidney function based on GFR.
Safety of LipoMicel Berberine - Fasting blood glucose
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in blood glucose levels based on fasting blood glucose.
Safety of LipoMicel Berberine - Total cholesterol (TC)
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on TC.
Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on LDL.
Safety of LipoMicel Berberine - High-density lipoprotein (HDL) cholesterol
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on HDL.
Safety of LipoMicel Berberine - Triglycerides (TG)
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on TG.
11 secondary outcomes
Tolerability of Treatment: Bloating
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Constipation
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Diarrhea
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Heartburn
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: cramps
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: knotted feeling in abdomen
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Rash
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Nausea
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Dizziness
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Blurred vision
Time frame: From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Other (unrelated to treatment)
Time frame: From enrollment to the end of treatment at 30 days
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 Dec 2024.
- 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.
Julia Solnier, PhD principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LipoMicel Berberine in people with Safety, run by Isura 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 3 inclusion and 8 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 Dec 2024. 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. 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?
Safety of LipoMicel Berberine - ALT (time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)). The study lists 10 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 13 Dec 2024.