Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels

Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05370261

Enrollment

Registered

2022-05-11

Start date

2022-02-01

Completion date

2022-05-04

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

Bioavailability, Berberine, LipoMicel, Pharmacokinetics

Brief summary

The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared. As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.

Interventions

DIETARY_SUPPLEMENTBerberine LipoMicel

Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine

DIETARY_SUPPLEMENTRegular Berberine hard-gels

Total dose of 500 mg of berberine

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 21-65 * healthy, good physical condition

Exclusion criteria

* Pregnancy or breast-feeding * Gastrointestinal conditions * Acute or chronic liver disease * Acute or chronic kidney disease * Acute or chronic cardiovascular disease * Hematological disease * Diabetes * Allergy or Intolerance to gluten * Allergy or Intolerance to Berberine * Use of any form of nicotine or tobacco * Alcohol and substance abuse history * Use of medications (e.g., blood sugar-lowering agents, or statins) * Use of Berberine supplements * Participation in another investigational study

Design outcomes

Primary

Measure	Time frame	Description
AUC: the area under the concentration-time curve	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)	To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Area under the plasma concentration versus time curve (AUC) with that of with free/regular berberine (hydrochloride).
Cmax: maximum plasma concentration	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)	To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Peak Plasma Concentration (Cmax) with that of with free/regular berberine (hydrochloride).
Tmax: the time point of maximum plasma concentration	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)	To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the time point of maximum plasma concentration (Tmax) with that of with free/regular berberine (hydrochloride).

Secondary

Measure	Time frame	Description
Effects on Blood sugar levels	0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)	To evaluate the immediate or short-term effects of orally ingested Berberine on blood sugar levels in healthy volunteers by using a glucose tolerance test (OGTT).
Changes in Blood sugar concentrations	0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)	To evaluate changes in blood sugar concentrations of orally ingested Berberine in healthy volunteers by using a portable glucometer.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026