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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
19
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
microcrystalline cellulose
Isura
Burnaby, British Columbia, Canada
Safety of LipoMicel Berberine - ALT
To evaluate changes in liver function based on ALT.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol
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To evaluate changes in lipid profile based on LDL.
Time frame: 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.
Time frame: 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.
Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 30 days