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

Factors Group of Nutritional Companies

Status: Completed

Conditions: Pharmacokinetics

Treatments: Dietary Supplement: Regular Berberine hard-gels; Dietary Supplement: Berberine LipoMicel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05370261

2021-08-004

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

12 participants in 2 patient groups

Berberine LipoMicel soft-gel

Experimental group

Description:

Each participant receives their treatment of Berberine LipoMicel soft-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning.

Treatment:

Dietary Supplement: Berberine LipoMicel

Regular Berberine hard-gel

Experimental group

Description:

Each participant receives their treatment of regular Berberine hard-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours. Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing. Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used. Adverse events are recorded throughout the study by direct questioning.

Treatment:

Dietary Supplement: Regular Berberine hard-gels