Safety Profile of a New Berberine Formulation with Improved Bioavailability

NCT06732908 | Completed

• 1 other identifier: 2022-11-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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. 1.Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days.
2. 2.Return to study site weekly for blood tests.
3. 3.Keep a diary of their symptoms (collection of adverse events).

Conditions

Safety

Keywords

berberine; LipoMicel; safety

Outcome Measures

Primary Outcomes (10)

• 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.

  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)

Secondary Outcomes (11)

• Tolerability of Treatment: Bloating

  From enrollment to the end of treatment at 30 days

• Tolerability of Treatment: Constipation

  From enrollment to the end of treatment at 30 days

• Tolerability of Treatment: Diarrhea

  From enrollment to the end of treatment at 30 days

• Tolerability of Treatment: Heartburn

  From enrollment to the end of treatment at 30 days

• Tolerability of Treatment: cramps

  From enrollment to the end of treatment at 30 days

Study Arms (2)

Berberine LipoMicel

ACTIVE COMPARATOR

1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days.

Dietary Supplement: LipoMicel Berberine

Placebo

PLACEBO COMPARATOR

Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days.

Other: Placebo

Interventions

LipoMicel Berberine DIETARY_SUPPLEMENT

Berberine powder in a LipoMicel matrix encapsulated in soft gel.

Berberine LipoMicel

Placebo OTHER

microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isura: lead

Study Sites (1)

Isura

Burnaby, British Columbia, V3N 4T5, Canada

Location

Study Officials

• Julia Solnier, PhD

  Isura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 13, 2024
• Study Start: May 27, 2024
• Primary Completion: August 27, 2024
• Study Completion: October 31, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)