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Completed

NCT Number: NCT06345950

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.

The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.

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Key information

Conditions

Bioavailability Heathy Volunteers Safety

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, V2N 4S9, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male or female aged 21-65 years
  • healthy, good physical condition
  • voluntary, written, informed consent to participate in the study.

Exclusion criteria

  • use of anti-inflammatory or non-steroidal anti-inflammatory drugs
  • previous history of cardiovascular disease or acute or chronic inflammatory disease
  • use of antioxidant supplements or cholesterol-lowering agents
  • change of diet habits or lifestyle (diet, physical activity, etc.)
  • alcohol or substance abuse history
  • use of nicotine or tobacco
  • participation in another investigational study

Treatment and study plan

Liposomal Glutathione

Dietary Supplement

A maximum single dose of 300 mg glutathione (hard gel capsules)

Standard Glutathione

Dietary Supplement

A maximum single dose of 500 mg glutathione (hard gel capsules)

New Micellar Glutathione (Lipomicel)

Dietary Supplement

A maximum single dose of 300 mg glutathione (soft gel capsules)

Primary outcomes

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

    Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

    To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing glutathione.

  2. Cmax: maximum plasma concentration

    Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

    To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing glutathione.

  3. Tmax: the time point of maximum plasma concentration

    Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

    To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing glutathione.

Secondary outcomes

  1. Alanine aminotransferase (ALT)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in liver function based on ALT.

  2. Aspartate aminotransferase (AST)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in liver function based on AST.

  3. Alkaline phosphatase (ALP)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in liver function based on ALP.

  4. Bilirubin

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in liver function based on Bilirubin.

  5. Serum creatinine

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in kidney function based on Serum creatinine.

  6. Blood urea nitrogen (BUN)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in kidney function based on BUN.

  7. Glomerular filtration rate (GFR)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in kidney function based on GFR.

  8. C-reactive protein (CRP)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in inflammatory response based on CRP.

  9. White blood cell count (WBC)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in complete blood count based on WBC.

  10. Hemoglobin (Hb)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in complete blood count based on Hb.

  11. Hematocrit (Hct)

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in complete blood count based on Hct.

  12. Platelet count

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in complete blood count based on Platelet count.

    .

  13. Fasting blood glucose

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in blood glucose levels based on fasting blood glucose.

  14. Total cholesterol

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in lipid profile based on total cholesterol.

  15. Low-density lipoprotein (LDL) cholesterol

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in lipid profile based on LDL.

  16. High-density lipoprotein (HDL) cholesterol

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in lipid profile based on HDL.

  17. Triglycerides

    Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

    To evaluate changes in lipid profile based on triglycerides.

Sponsors and collaborators

Lead sponsor

Factors Group of Nutritional Companies Inc.

Industry

Collaborators

  • Isura

Registry information

Official study title

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Feb 27, 2026

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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