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

NCT05370261 | Completed

• 1 other identifier: 2021-08-004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

Bioavailability; Berberine; LipoMicel; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

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

Secondary Outcomes (2)

• Effects on Blood sugar levels

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

• Changes in Blood sugar concentrations

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

Study Arms (2)

Berberine LipoMicel soft-gel

EXPERIMENTAL

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.

Dietary Supplement: Berberine LipoMicel

Regular Berberine hard-gel

EXPERIMENTAL

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.

Dietary Supplement: Regular Berberine hard-gels

Interventions

Berberine LipoMicel DIETARY_SUPPLEMENT

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

Berberine LipoMicel soft-gel

Regular Berberine hard-gels DIETARY_SUPPLEMENT

Total dose of 500 mg of berberine

Regular Berberine hard-gel

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• healthy, good physical condition

You may not qualify if:

• 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

Sponsors & Collaborators

• Factors Group of Nutritional Companies Inc.: lead

Study Sites (1)

ISURA

Burnaby, British Columbia, V3N4S9, Canada

Location

Related Publications (1)

• Solnier J, Zhang Y, Kuo YC, Du M, Roh K, Gahler R, Wood S, Chang C. Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers. Pharmaceutics. 2023 Nov 1;15(11):2567. doi: 10.3390/pharmaceutics15112567.

  PMID: 38004546 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 11, 2022
• Study Start: February 1, 2022
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

CA (1)