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Completed

NCT Number: NCT06732908

Safety Profile of a New Berberine Formulation with Improved Bioavailability

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).

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Key information

Conditions

Safety

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isura

Burnaby, British Columbia, V3N 4T5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LipoMicel Berberine

Dietary Supplement

Berberine powder in a LipoMicel matrix encapsulated in soft gel.

Placebo

Other

microcrystalline cellulose

Primary outcomes

  1. Safety of LipoMicel Berberine - ALT

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in liver function based on ALT.

  2. Safety of Lipomicel Berberine - AST

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in liver function based on AST.

  3. Safety of LipoMicel Berberine - Bilirubin

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in liver function based on bilirubin.

  4. Safety of LipoMicel Berberine - Serum creatinine

    Time frame: 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.

  5. Safety of LipoMicel Berberine - Glomerular filtration rate (GFR)

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in kidney function based on GFR.

  6. Safety of LipoMicel Berberine - Fasting blood glucose

    Time frame: 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.

  7. Safety of LipoMicel Berberine - Total cholesterol (TC)

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in lipid profile based on TC.

  8. Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in lipid profile based on LDL.

  9. Safety of LipoMicel Berberine - High-density lipoprotein (HDL) cholesterol

    Time frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

    To evaluate changes in lipid profile based on HDL.

  10. Safety of LipoMicel Berberine - Triglycerides (TG)

    Time frame: 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 outcomes

  1. Tolerability of Treatment: Bloating

    Time frame: 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.

  2. Tolerability of Treatment: Constipation

    Time frame: 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.

  3. Tolerability of Treatment: Diarrhea

    Time frame: 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.

  4. Tolerability of Treatment: Heartburn

    Time frame: 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.

  5. Tolerability of Treatment: cramps

    Time frame: 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.

  6. Tolerability of Treatment: knotted feeling in abdomen

    Time frame: 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.

  7. Tolerability of Treatment: Rash

    Time frame: 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.

  8. Tolerability of Treatment: Nausea

    Time frame: 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.

  9. Tolerability of Treatment: Dizziness

    Time frame: 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.

  10. Tolerability of Treatment: Blurred vision

    Time frame: 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.

  11. Tolerability of Treatment: Other (unrelated to treatment)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Isura

Other

Registry information

Official study title

Evaluating the Safety and Tolerability of LipoMicel Berberine

Acronym: Berberine Safe

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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