Safety Profile of a New Berberine Formulation with Improved Bioavailability
NCT ID: NCT06732908
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2024-05-27
2024-10-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Berberine LipoMicel
1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days.
LipoMicel Berberine
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
Placebo
Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days.
Placebo
microcrystalline cellulose
Interventions
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LipoMicel Berberine
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
Placebo
microcrystalline cellulose
Eligibility Criteria
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Inclusion Criteria
* Completed an online health questionnaire on their medical history
* A voluntarily signed informed consent form.
Exclusion Criteria
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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Isura
OTHER
Responsible Party
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Principal Investigators
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Julia Solnier, PhD
Role: PRINCIPAL_INVESTIGATOR
Isura
Locations
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Isura
Burnaby, British Columbia, Canada
Countries
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Other Identifiers
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2022-11-002
Identifier Type: -
Identifier Source: org_study_id