Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

NCT06345950 | Completed

• 1 other identifier: 2022-04-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bioavailability Heathy Volunteers; Safety

Keywords

pharmacokinetics; glutathione; bioavailability; safety; micellar delivery system

Outcome Measures

Primary Outcomes (3)

• AUC: the area under the concentration-time curve

  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.

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

• Cmax: maximum plasma concentration

  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.

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

• Tmax: the time point of maximum plasma concentration

  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.

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

Secondary Outcomes (17)

• Alanine aminotransferase (ALT)

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

• Aspartate aminotransferase (AST)

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

• Alkaline phosphatase (ALP)

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

• Bilirubin

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

• Serum creatinine

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

Study Arms (3)

Liposomal Glutathione

EXPERIMENTAL

Each participant receives their treatment i.e., Liposomal Glutathione hard gel capsules at a total dose of 300 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 1 week between each treatment is used.

Dietary Supplement: Liposomal Glutathione

Standard Glutathione

EXPERIMENTAL

Each participant receives their treatment i.e., Standard Glutathione hard gel capsules at a total dose of 500 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 1 week between each treatment is used.

Dietary Supplement: Standard Glutathione

New Micellar Glutathione (Lipomicel)

EXPERIMENTAL

Each participant receives their treatment i.e., LipoMicel Glutathione soft gel capsules at a total dose of 300 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 1 week between each treatment is used.

Dietary Supplement: New Micellar Glutathione (Lipomicel)

Interventions

Liposomal Glutathione DIETARY_SUPPLEMENT

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

Liposomal Glutathione

Standard Glutathione DIETARY_SUPPLEMENT

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

Standard Glutathione

New Micellar Glutathione (Lipomicel) DIETARY_SUPPLEMENT

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

New Micellar Glutathione (Lipomicel)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Factors Group of Nutritional Companies Inc.: lead
• Isura: collaborator

Study Sites (1)

ISURA

Burnaby, British Columbia, V2N 4S9, Canada

Location

Related Publications (1)

• Solnier J, Du M, Zhang Y, Roh YS, Kuo YC, Ibi A, Wood S, Hardy M, Gahler RJ, Chang C. A Targeted Metabolomic Assessment of Oral Glutathione Bioavailability and Safety in Humans: A Randomized Crossover Clinical Trial. Antioxidants (Basel). 2026 Mar 11;15(3):354. doi: 10.3390/antiox15030354.

  PMID: 41897500 DERIVED

MeSH Terms

Interventions

glutathione pegylated liposomal doxorubicin

Study Officials

• Julia Solnier, PhD

  Isura

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: June 21, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CA (1)