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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine LipoMicel | Active Comparator | 1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days. |
|
| Placebo | Placebo Comparator | Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipoMicel Berberine | Dietary Supplement | Berberine powder in a LipoMicel matrix encapsulated in soft gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of LipoMicel Berberine - ALT | To evaluate changes in liver function based on ALT. | 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 30 days |
| Tolerability of Treatment: Constipation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Solnier, PhD | Isura | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isura | Burnaby | British Columbia | V3N 4T5 | Canada |
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| Placebo | Other | microcrystalline cellulose |
|
| 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. | 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. | 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. | 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose) |
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 30 days |