Glutathione-cyclodextrin Complex AbsorptionPhase 1NCT05926245
Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
A Phase 1 study testing Glutaryl Solution in people with Glutathione-cyclodextrin Complex Absorption, run by Western University of Health Sciences at 1 site in United States.
Trial summary
The proposed clinical trial will confirm the therapeutic absorption of glutathione following topical Glutaryl application in increasing blood GSH levels without an invasive procedure. GOAL: Confirm therapeutic level of glutathione following topical transdermal application. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glutathione-cyclodextrin Complex Absorption
- What is being tested?
- Glutaryl Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 14 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1 (Control group) will include 15 healthy volunteers with the age group between 21-65. Participants belonging to Group 1 will be recruited from the local area. Group 1 will serve as controls for Group 2.
- Group 2 (Glutathione Group) will include 15 healthy volunteers that are not allergic to any components of GlutarylTM who will be sprayed four times twice a day for three days with Topical glutathione Complex (GlutarylTM) formulation on their skin on their ventral part of the abdomen.
- Components of Glutaryl:
- Main ingredients of Glutaryl are Glutathione, ascorbic acid and cyclodextrin. The preservative system used is potassium sorbate and radish root extracts.
Who cannot join
- Pregnant and breastfeeding women. Anyone below age of 21 or above age of 65. Patients with active cancer. Patients with known liver disease, hepatitis, COVD-19, HIV, or AIDS. Patients taking some form of glutathione. Subjects who have previously fainted following venipuncture will also be excluded. By interviewing the subjects we will determine whether or not the subject will be excluded from the study based on their previous phlebotomy experiences.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
The proposed clinical trial will confirm the therapeutic absorption of glutathione following topical Glutaryl application in increasing blood GSH levels without an invasive procedure.
GOAL: Confirm therapeutic level of glutathione following topical transdermal application.
Read more
HYPOTHESIS: The hypothesis of the proposed study is that the glutathione administration will increase RBC levels of glutathione above 80%.
AIM: Determine a non-invasive way to increase glutathione levels in the plasma and blood cells.
This aim will be accomplished as follows:
STEP 1: We will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or N-acetyl cysteine (NAC) supplementation.
STEP 2: Determine baseline levels of GSH, free radicals and cytokines through analysis of venipuncture blood draws.
STEP 3: Study subjects will be asked to spray themselves with either placebo or Glutaryl four times twice a day for three days on the ventral part of the abdomen. Measure the levels of GSH, free radicals and cytokines after 1 hour, 4 hour and 72 hours.
- Being tested
- Glutaryl Solution, Placebo Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutaryl SolutionDietary supplement
Glutathione, ascorbic acid, cyclodextrin, potassium sorbate and radish root extracts
Placebo SolutionDietary supplement
Empty nanoparticles
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | 15 adult healthy volunteers to serve as controls for the experimental group. This group will receive a placebo-topical spray with empty nanoparticles. Receives: Dietary Supplement: Placebo Solution |
| Glutathione Group | Experimental | 15 adult healthy volunteers will serve in the experimental group. This group will receive glutaryl treatment topical spray with nanoparticles containing GSH. Receives: Dietary Supplement: Glutaryl Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSH
Levels of total, reduced, and oxidized forms of GSH in the isolated plasma, red blood cells (RBCs) and peripheral blood mononuclear cells (PBMCs) isolated from the peripheral blood of the two-study groups will be assayed by spectrophotometry using an assay kit from Arbor Assays (3-12).
Measured: 72 hours
Secondary outcomes (2)
Free Radicals
To demonstrate that increased levels of GSH in the experimental group is accompanied by decreased levels of reactive oxygen species (ROS), free radical activity will be measured by malondialdehyde (MDA) assay that measures several end products of lipid peroxidation (3-12).
Measured: 72 hours
Pro- and Anti-inflammatory Cytokines
To demonstrate that increased levels of GSH in the experimental group is accompanied by altered levels of pro- and anti-inflammatory cytokines and chemokines, we will measure the levels of pro- and anti-inflammatory cytokines and cytokines in the plasma derived from the two study groups by ELISA using an assay kit from ThermoFisher.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Jul 2022
- Primary completion2 Aug 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glutathione-cyclodextrin Complex AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Badaoui, Western University of Health Sciences
- Investigators
- Cesar Ochoa, MD, Study director, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926245
- Sponsor's protocol ID
- antioxidants-2402271
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
- ClinicalTrials.gov ID
- NCT05926245
- Acronym / sponsor ID
- antioxidants-2402271
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed clinical trial will confirm the therapeutic absorption of glutathione following topical Glutaryl application in increasing blood GSH levels without an invasive procedure.
GOAL: Confirm therapeutic level of glutathione following topical transdermal application.
HYPOTHESIS: The hypothesis of the proposed study is that the glutathione administration will increase RBC levels of glutathione above 80%.
AIM: Determine a non-invasive way to increase glutathione levels in the plasma and blood cells.
This aim will be accomplished as follows:
STEP 1: We will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or N-acetyl cysteine (NAC) supplementation.
STEP 2: Determine baseline levels of GSH, free radicals and cytokines through analysis of venipuncture blood draws.
STEP 3: Study subjects will be asked to spray themselves with either placebo or Glutaryl four times twice a day for three days on the ventral part of the abdomen. Measure the levels of GSH, free radicals and cytokines after 1 hour, 4 hour and 72 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo Solution15 adult healthy volunteers to serve as controls for the experimental group. This group will receive a placebo-topical spray with empty nanoparticles. |
| Glutathione Group | Experimental | Dietary Supplement: Glutaryl Solution15 adult healthy volunteers will serve in the experimental group. This group will receive glutaryl treatment topical spray with nanoparticles containing GSH. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Group 1 (Control group) will include 15 healthy volunteers with the age group between 21-65. Participants belonging to Group 1 will be recruited from the local area. Group 1 will serve as controls for Group 2.
- Group 2 (Glutathione Group) will include 15 healthy volunteers that are not allergic to any components of GlutarylTM who will be sprayed four times twice a day for three days with Topical glutathione Complex (GlutarylTM) formulation on their skin on their ventral part of the abdomen.
- Main ingredients of Glutaryl are Glutathione, ascorbic acid and cyclodextrin. The preservative system used is potassium sorbate and radish root extracts.
Key exclusion criteria (1 listed)
- Pregnant and breastfeeding women. Anyone below age of 21 or above age of 65. Patients with active cancer. Patients with known liver disease, hepatitis, COVD-19, HIV, or AIDS. Patients taking some form of glutathione. Subjects who have previously fainted following venipuncture will also be excluded. By interviewing the subjects we will determine whether or not the subject will be excluded from the study based on their previous phlebotomy experiences.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutaryl SolutionGlutathione, ascorbic acid, cyclodextrin, potassium sorbate and radish root extracts | Dietary supplement | Glutathione Group |
| Placebo SolutionEmpty nanoparticles | Dietary supplement | Placebo Group |
Primary outcome
GSH
Time frame: 72 hours
Levels of total, reduced, and oxidized forms of GSH in the isolated plasma, red blood cells (RBCs) and peripheral blood mononuclear cells (PBMCs) isolated from the peripheral blood of the two-study groups will be assayed by spectrophotometry using an assay kit from Arbor Assays (3-12).
2 secondary outcomes
Free Radicals
Time frame: 72 hours
Pro- and Anti-inflammatory Cytokines
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar Ochoa, MD study director
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glutaryl Solution in people with Glutathione-cyclodextrin Complex Absorption, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSH (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.