Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06345950
Other study ID # 2022-04-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2022
Est. completion date June 30, 2023

Study information

Verified date March 2024
Source Factors Group of Nutritional Companies Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Liposomal Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
Standard Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
New Micellar Glutathione (Lipomicel)
A maximum single dose of 600 mg glutathione (soft gel capsules)

Locations

Country Name City State
Canada ISURA Burnaby British Columbia

Sponsors (2)

Lead Sponsor Collaborator
Factors Group of Nutritional Companies Inc. Isura

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 Alanine aminotransferase (ALT) To evaluate changes in liver function based on ALT. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Aspartate aminotransferase (AST) To evaluate changes in liver function based on AST. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Alkaline phosphatase (ALP) To evaluate changes in liver function based on ALP. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Bilirubin To evaluate changes in liver function based on Bilirubin. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Serum creatinine To evaluate changes in kidney function based on Serum creatinine. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Blood urea nitrogen (BUN) To evaluate changes in kidney function based on BUN. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Glomerular filtration rate (GFR) To evaluate changes in kidney function based on GFR. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary C-reactive protein (CRP) To evaluate changes in inflammatory response based on CRP. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary White blood cell count (WBC) To evaluate changes in complete blood count based on WBC. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Hemoglobin (Hb) To evaluate changes in complete blood count based on Hb. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Hematocrit (Hct) To evaluate changes in complete blood count based on Hct. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Platelet count To evaluate changes in complete blood count based on Platelet count.
.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Fasting blood glucose To evaluate changes in blood glucose levels based on fasting blood glucose. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Total cholesterol To evaluate changes in lipid profile based on total cholesterol. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Low-density lipoprotein (LDL) cholesterol To evaluate changes in lipid profile based on LDL. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary High-density lipoprotein (HDL) cholesterol To evaluate changes in lipid profile based on HDL. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Secondary Triglycerides To evaluate changes in lipid profile based on triglycerides. 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
See also
  Status Clinical Trial Phase
Recruiting NCT05073744 - Nalbuphine Versus Morphine for Perioperative Tumor Ablation Phase 4
Completed NCT03969641 - Safety of RIV4 Versus IIV4 in Pregnant Women Phase 4
Completed NCT05592951 - Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers N/A
Completed NCT04693429 - Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+ Phase 1
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01243502 - A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers Phase 1
Completed NCT06072170 - Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience Phase 1
Completed NCT05076253 - Efficacy of Ivermectin in COVID-19 Phase 1/Phase 2
Recruiting NCT06060379 - Giochiamo 626 - Gaming for Health and Safety in Workplaces N/A
Recruiting NCT05298800 - Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23 Phase 4
Completed NCT05188638 - Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects Phase 1
Completed NCT05145621 - Oral Bio-equivalence Study Phase 1
Recruiting NCT05580159 - New Generation mRNA Booster Vaccine Against Emerging VOCs Phase 3
Not yet recruiting NCT04596956 - Safety and Efficacy of Sodium Bicarbonate Ringer Injection Phase 4
Completed NCT03033329 - Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4 Phase 1
Terminated NCT01929811 - NeoMET Study in Neoadjuvant Treatment of Breast Cancer Phase 2
Completed NCT01193335 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants. Phase 4
Completed NCT03300466 - A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds N/A
Active, not recruiting NCT05686161 - mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs Phase 3