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

Factors Group of Nutritional Companies Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pharmacokinetics

Interventions

Berberine LipoMicelDIETARY_SUPPLEMENT

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

Regular Berberine hard-gelsDIETARY_SUPPLEMENT

Total dose of 500 mg of berberine

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ISURA

Burnaby, British Columbia, Canada

Outcomes

Primary Outcomes

AUC: the area under the concentration-time curve

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).

Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)

Cmax: maximum plasma concentration

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).

Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)

Tmax: the time point of maximum plasma concentration

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).

Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)

Secondary Outcomes

Effects on Blood sugar levels

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).

Time frame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)

Changes in Blood sugar concentrations

To evaluate changes in blood sugar concentrations of orally ingested Berberine in healthy volunteers by using a portable glucometer.

Time frame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)

Data from ClinicalTrials.gov

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