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Completed

NCT Number: NCT05370261

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

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.

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Key information

Conditions

Pharmacokinetics

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, V3N4S9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berberine LipoMicel

Dietary Supplement

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

Regular Berberine hard-gels

Dietary Supplement

Total dose of 500 mg of berberine

Primary outcomes

  1. AUC: the area under the concentration-time curve

    Time frame: 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).

  2. Cmax: maximum plasma concentration

    Time frame: 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).

  3. Tmax: the time point of maximum plasma concentration

    Time frame: 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 outcomes

  1. Effects on Blood sugar levels

    Time frame: 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).

  2. Changes in Blood sugar concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Factors Group of Nutritional Companies Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 11, 2022
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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