Safety
Conditions
Keywords
berberine, LipoMicel, safety
Brief 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 tolerated in healthy individuals? Participants will: 1. Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days. 2. Return to study site weekly for blood tests. 3. Keep a diary of their symptoms (collection of adverse events).
Interventions
DIETARY_SUPPLEMENTLipoMicel Berberine
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
OTHERPlacebo
microcrystalline cellulose
Sponsors
Isura
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of LipoMicel Berberine - ALT | 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 | 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 | 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 | 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) | 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 | 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) | 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 | 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 | 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) | 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose) | To evaluate changes in lipid profile based on TG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Treatment: Bloating | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Other (unrelated to treatment) | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Constipation | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Diarrhea | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Heartburn | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: cramps | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: knotted feeling in abdomen | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Rash | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Nausea | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Dizziness | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
| Tolerability of Treatment: Blurred vision | From enrollment to the end of treatment at 30 days | To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening. |
Countries
Canada
Outcome results
None listed