An interventional study of LipoMicel Berberine and Placebo in Safety, sponsored by Isura. Completed at 1 site in Canada. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Isura · Not applicable, Interventional, and Other
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:
Isura is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days.
Dietary Supplement: LipoMicel Berberine
Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days.
Other: Placebo
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
microcrystalline cellulose
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Isura