Clinical trial NCT06732908: Safety Profile of a New Berberine Formulation with Improved Bioavailability
Official title: Evaluating the Safety and Tolerability of LipoMicel Berberine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety
Keywords: berberine
LipoMicel
safety
Lead sponsor: Isura
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety of LipoMicel Berberine - ALT
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of Lipomicel Berberine - AST
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Bilirubin
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Serum creatinine
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Glomerular filtration rate (GFR)
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Fasting blood glucose
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Total cholesterol (TC)
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - High-density lipoprotein (HDL) cholesterol
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
measure: Safety of LipoMicel Berberine - Triglycerides (TG)
timeFrame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Secondary outcomes:
measure: Tolerability of Treatment: Bloating
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Constipation
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Diarrhea
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Heartburn
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: cramps
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: knotted feeling in abdomen
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Rash
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Nausea
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Dizziness
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Blurred vision
timeFrame: From enrollment to the end of treatment at 30 days
measure: Tolerability of Treatment: Other (unrelated to treatment)
timeFrame: From enrollment to the end of treatment at 30 days
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Isura
state: British Columbia
Study officials:
affiliation: Isura
name: Julia Solnier, PhD
role: PRINCIPAL_INVESTIGATOR
References: