PharmacokineticsNCT06252519
Pharmacokinetic Profile of N-Acetyl Cysteine
A study testing NAC, Neuro-NAC and Neuro-NAC XS in people with Pharmacokinetics, run by University of Memphis at 1 site in United States.
Trial summary
The study compares three different formulations containing N-Acetyl Cysteine, with regards to acute absorption over a 24-hour period, following single ingestion. The formulations are traditional N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester, and a product containing a combination of N-Acetyl Cysteine Ethyl Ester… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- NAC, Neuro-NAC and Neuro-NAC XS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 22 May 2024
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active (2 or more days per week of exercise for greater than 30 minutes/day)
- Body mass index between 18-29.9 kilograms per meter squared
- fast overnight (greater than 10 hours)
- willing to adhere to study procedures
Who cannot join
- tobacco user
- chronic disease, including diagnosed digestive disorders
- allergy or sensitivity to study product
- alcohol consumption within 24 hours of study visit
- caffeine consumption within 24 hours of study visit
- active infection or illness
- lactating, pregnant, planning to become pregnant during study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
Official title: Pharmacokinetic Profile of N-Acetyl Cysteine in Self-reported Healthy Men and Women
The study compares three different formulations containing N-Acetyl Cysteine, with regards to acute absorption over a 24-hour period, following single ingestion. The formulations are traditional N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester, and a product containing a combination of N-Acetyl Cysteine Ethyl Ester, glycine, and two minerals with antioxidant potential (selenium and molybdenum) that might enhance the effect of N-Acetyl Cysteine Ethyl Ester. Subjects will report to the lab on three different occasions to consume the products, using a randomized cross-over design, and blood will be collected periodically (for the initial 8 hours and then again at 24 hours) per standard, routinely used pharmacokinetic /pharmacodynamic study protocols for evaluation of circulating glutathione concentrations. The hypothesis for this study is that the combination of N-Acetyl Cysteine Ethyl Ester + glycine will yield the greatest increase in glutathione, followed by N-Acetyl Cysteine Ethyl Ester, followed by N-Acetyl Cysteine. These findings will provide initial evidence specific to the bioavailability of these treatments following a single acute ingestion and may guide future recommendations regarding routine use.
Read the detailed description
One method of enhancing the uptake of N-Acetyl Cysteine following oral ingestion is to use the ethyl ester form, referred to as N-Acetyl Cysteine Ethyl Ester, which exerts remarkable antioxidant potential . N-Acetyl Cysteine Ethyl Ester is also available as a dietary supplement, has been well-investigated and known to be much more effective than traditional N-Acetyl Cysteine, in terms of elevating glutathione levels. In addition, recent work indicates that inclusion of the amino acid glycine along with very high dose N-Acetyl Cysteine results in an increase in glutathione, which may have health enhancing benefits for a variety of conditions. Such an elevation in glutathione may provide for antioxidant benefits which can reduce oxidative stress and possibly aid various aspects of overall health, as oxidative stress is associated with disease and aging.
The study compares three different formulations containing N-Acetyl Cysteine, with regards to acute absorption over a 24-hour period, following single ingestion. The formulations are traditional N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester, and a product containing a combination of N-Acetyl Cysteine Ethyl Ester, glycine, and two minerals with antioxidant potential (selenium and molybdenum) that might enhance the effect of N-Acetyl Cysteine Ethyl Ester. Subjects will report to the lab on three different occasions to consume the products, using a randomized cross-over design, and blood will be collected periodically (for the initial 8 hours and then again at 24 hours) per standard, routinely used pharmacokinetic /pharmacodynamic study protocols for evaluation of circulating glutathione concentrations. The hypothesis for this study is that the combination of N-Acetyl Cysteine Ethyl Ester + glycine will yield the greatest increase in glutathione, followed by N-Acetyl Cysteine Ethyl Ester, followed by N-Acetyl Cysteine. These findings will provide initial evidence specific to the bioavailability of these treatments following a single acute ingestion and may guide future recommendations regarding routine use.
- Conditions
- Pharmacokinetics
- Being tested
- NAC, Neuro-NAC, Neuro-NAC XS
- Keywords
- N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NACDietary supplement
1 375 mg capsule containing N-acetyl cysteine
Neuro-NACDietary supplement
3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester
Neuro-NAC XSDietary supplement
3 capsules containing a total of 75 mcg Selenium, 150 mcg Molybdenum, 1800 mg Glycine, and 375 mg N-Acetyl L-Cysteine Ethyl Ester
| Study group | Role | What they receive |
|---|---|---|
| NAC, then neuro-NAC, then Neuro-NAC XS | Experimental | Participants receive single dose of NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet. Receives: Dietary Supplement: NAC; Dietary Supplement: Neuro-NAC; Dietary Supplement: Neuro-NAC XS |
| NAC, Neuro-NAC XS, then Neuro-NAC | Experimental | Participants receive single dose of NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet.
One week later, participants receive 1 dose Neuro-NAC while on controlled diet. Receives: Dietary Supplement: NAC; Dietary Supplement: Neuro-NAC; Dietary Supplement: Neuro-NAC XS |
| Neuro-NAC, then NAC, then Neuro-NAC XS | Experimental | Participants receive single dose of Neuro-NAC while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet. Receives: Dietary Supplement: NAC; Dietary Supplement: Neuro-NAC; Dietary Supplement: Neuro-NAC XS |
| Neuro-NAC, then Neuro-NAC XS, then NAC | Experimental | Participants receive single dose of Neuro-NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet.
One week later, participants receive 1 dose NAC while on controlled diet. Receives: Dietary Supplement: NAC; Dietary Supplement: Neuro-NAC; Dietary Supplement: Neuro-NAC XS |
| Neuro-NAC XS, then NAC, then Neuro-NAC | Experimental | Participants receive single dose of Neuro-NAC XS while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. Receives: Dietary Supplement: NAC; Dietary Supplement: Neuro-NAC; Dietary Supplement: Neuro-NAC XS |
| Neuro-NAC XS, then Neuro-NAC, then NAC | Experimental | Participants receive single dose of Neuro-NAC XS while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. Receives: Dietary Supplement: NAC; Dietary Supplement: Neuro-NAC; Dietary Supplement: Neuro-NAC XS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration curve for glutathione
The area under the concentration curve for reduced glutathione over oxidized glutathione will be calculated for each supplement.
Measured: 24 hour period following supplement ingestion
Terminal Half-life of glutathione
The terminal half-life of reduced glutathione over oxidized glutathione will be calculated for each supplement
Measured: 24 hour period following supplement ingestion
Peak concentration of glutathione
The peak concentration of reduced glutathione over oxidized glutathione will be determined for each supplement
Measured: 24 hour period following supplement ingestion
Time to maximum concentration
The time to reaching the maximum concentration of reduced glutathione over oxidized glutathione will be determined for each supplement
Measured: 24 hour period following supplement ingestion
Lag time
The lag time of each supplement will be determined.
Measured: 24 hour period following supplement ingestion
Apparent volume distribution during terminal elimination phase
The apparent volume distribution during terminal elimination phase will be determined for reduced glutathione over oxidized glutathione
Measured: 24 hour period following supplement ingestion
Oral Clearance of glutathione
The oral clearance of each supplement will be determined.
Measured: 24 hour period following supplement ingestion
Secondary outcomes (20)
Blood Malondialdehyde
The concentration of malondialdehyde in blood will be measured in millimoles per liter
Measured: 0 min prior to supplement ingestion (baseline)
Blood Malondialdehyde
The concentration of malondialdehyde in blood will be measured millimoles per liter
Measured: 2 hours following supplement ingestion
Blood Malondialdehyde
The concentration of malondialdehyde in blood will be measured millimoles per liter
Measured: 4 hours following supplement ingestion
Blood Malondialdehyde
The concentration of malondialdehyde in blood will be measured millimoles per liter
Measured: 8 hours following supplement ingestion
Blood Malondialdehyde
The concentration of malondialdehyde in blood will be measured millimoles per liter
Measured: 24 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter
Measured: 0 min prior to supplement ingestion (baseline)
Blood Advanced Oxidation Protein Products
The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter
Measured: 2 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter
Measured: 4 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter
Measured: 8 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter
Measured: 24 hours following supplement ingestion
Brunel Mood Scale
The brunel mood scale is a 24-item scale that consists of basic mood descriptors rated by the subject using a 5-point Likert scale where a score of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely.
Measured: 0 min prior to supplement ingestion (baseline)
Brunel Mood Scale
The brunel mood scale is a 24-item scale that consists of basic mood descriptors rated by the subject using a 5-point Likert scale where a score of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely.
Measured: 2 hours following supplement ingestion
Brunel Mood Scale
The brunel mood scale is a 24-item scale that consists of basic mood descriptors rated by the subject using a 5-point Likert scale where a score of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely.
Measured: 4 hours following supplement ingestion
Brunel Mood Scale
The brunel mood scale is a 24-item scale that consists of basic mood descriptors rated by the subject using a 5-point Likert scale where a score of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely.
Measured: 8 hours following supplement ingestion
Brunel Mood Scale
The brunel mood scale is a 24-item scale that consists of basic mood descriptors rated by the subject using a 5-point Likert scale where a score of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely.
Measured: 24 hours following supplement ingestion
Subjective Feelings
Subjective feelings will be self-assessed by subjects for energy, mood, motivation, focus, attention, irritability, and jitters the subject using a 100 mm visual analog scale from 0 (none) to 10 (extreme)
Measured: 0 min prior to supplement ingestion (baseline)
Subjective Feelings
Subjective feelings will be self-assessed by subjects for energy, mood, motivation, focus, attention, irritability, and jitters the subject using a 100 mm visual analog scale from 0 (none) to 10 (extreme)
Measured: 2 hours following supplement ingestion
Subjective Feelings
Subjective feelings will be self-assessed by subjects for energy, mood, motivation, focus, attention, irritability, and jitters the subject using a 100 mm visual analog scale from 0 (none) to 10 (extreme)
Measured: 4 hours following supplement ingestion
Subjective Feelings
Subjective feelings will be self-assessed by subjects for energy, mood, motivation, focus, attention, irritability, and jitters the subject using a 100 mm visual analog scale from 0 (none) to 10 (extreme)
Measured: 8 hours following supplement ingestion
Subjective Feelings
Subjective feelings will be self-assessed by subjects for energy, mood, motivation, focus, attention, irritability, and jitters the subject using a 100 mm visual analog scale from 0 (none) to 10 (extreme)
Measured: 24 hours following supplement ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start18 Sep 2023
- Primary completion13 Dec 2023
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over single-blinded study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Nature Fusions
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252519
- Sponsor's protocol ID
- PRO-FY2023-417
- Status last verified
- Dec 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Profile of N-Acetyl Cysteine in Self-reported Healthy Men and Women
- ClinicalTrials.gov ID
- NCT06252519
- Acronym / sponsor ID
- PRO-FY2023-417
- Conditions
- Pharmacokinetics
- Keywords
- N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Nature Fusions
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 9 Feb 2024 (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 study compares three different formulations containing N-Acetyl Cysteine, with regards to acute absorption over a 24-hour period, following single ingestion. The formulations are traditional N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester, and a product containing a combination of N-Acetyl Cysteine Ethyl Ester, glycine, and two minerals with antioxidant potential (selenium and molybdenum) that might enhance the effect of N-Acetyl Cysteine Ethyl Ester. Subjects will report to the lab on three different occasions to consume the products, using a randomized cross-over design, and blood will be collected periodically (for the initial 8 hours and then again at 24 hours) per standard, routinely used pharmacokinetic /pharmacodynamic study protocols for evaluation of circulating glutathione concentrations. The hypothesis for this study is that the combination of N-Acetyl Cysteine Ethyl Ester + glycine will yield the greatest increase in glutathione, followed by N-Acetyl Cysteine Ethyl Ester, followed by N-Acetyl Cysteine. These findings will provide initial evidence specific to the bioavailability of these treatments following a single acute ingestion and may guide future recommendations regarding routine use.
Detailed description
One method of enhancing the uptake of N-Acetyl Cysteine following oral ingestion is to use the ethyl ester form, referred to as N-Acetyl Cysteine Ethyl Ester, which exerts remarkable antioxidant potential . N-Acetyl Cysteine Ethyl Ester is also available as a dietary supplement, has been well-investigated and known to be much more effective than traditional N-Acetyl Cysteine, in terms of elevating glutathione levels. In addition, recent work indicates that inclusion of the amino acid glycine along with very high dose N-Acetyl Cysteine results in an increase in glutathione, which may have health enhancing benefits for a variety of conditions. Such an elevation in glutathione may provide for antioxidant benefits which can reduce oxidative stress and possibly aid various aspects of overall health, as oxidative stress is associated with disease and aging.
The study compares three different formulations containing N-Acetyl Cysteine, with regards to acute absorption over a 24-hour period, following single ingestion. The formulations are traditional N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester, and a product containing a combination of N-Acetyl Cysteine Ethyl Ester, glycine, and two minerals with antioxidant potential (selenium and molybdenum) that might enhance the effect of N-Acetyl Cysteine Ethyl Ester. Subjects will report to the lab on three different occasions to consume the products, using a randomized cross-over design, and blood will be collected periodically (for the initial 8 hours and then again at 24 hours) per standard, routinely used pharmacokinetic /pharmacodynamic study protocols for evaluation of circulating glutathione concentrations. The hypothesis for this study is that the combination of N-Acetyl Cysteine Ethyl Ester + glycine will yield the greatest increase in glutathione, followed by N-Acetyl Cysteine Ethyl Ester, followed by N-Acetyl Cysteine. These findings will provide initial evidence specific to the bioavailability of these treatments following a single acute ingestion and may guide future recommendations regarding routine use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Randomized cross-over single-blinded study
| Arm | Type | Receives |
|---|---|---|
| NAC, then neuro-NAC, then Neuro-NAC XS | Experimental | Dietary Supplement: NAC, Dietary Supplement: Neuro-NAC, Dietary Supplement: Neuro-NAC XSParticipants receive single dose of NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet. |
| NAC, Neuro-NAC XS, then Neuro-NAC | Experimental | Dietary Supplement: NAC, Dietary Supplement: Neuro-NAC, Dietary Supplement: Neuro-NAC XSParticipants receive single dose of NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. |
| Neuro-NAC, then NAC, then Neuro-NAC XS | Experimental | Dietary Supplement: NAC, Dietary Supplement: Neuro-NAC, Dietary Supplement: Neuro-NAC XSParticipants receive single dose of Neuro-NAC while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet. |
| Neuro-NAC, then Neuro-NAC XS, then NAC | Experimental | Dietary Supplement: NAC, Dietary Supplement: Neuro-NAC, Dietary Supplement: Neuro-NAC XSParticipants receive single dose of Neuro-NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC XS while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. |
| Neuro-NAC XS, then NAC, then Neuro-NAC | Experimental | Dietary Supplement: NAC, Dietary Supplement: Neuro-NAC, Dietary Supplement: Neuro-NAC XSParticipants receive single dose of Neuro-NAC XS while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. |
| Neuro-NAC XS, then Neuro-NAC, then NAC | Experimental | Dietary Supplement: NAC, Dietary Supplement: Neuro-NAC, Dietary Supplement: Neuro-NAC XSParticipants receive single dose of Neuro-NAC XS while on controlled diet. One week later, participants receive 1 dose Neuro-NAC while on controlled diet. One week later, participants receive 1 dose NAC while on controlled diet. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Recreationally active (2 or more days per week of exercise for greater than 30 minutes/day)
- Body mass index between 18-29.9 kilograms per meter squared
- fast overnight (greater than 10 hours)
- willing to adhere to study procedures
Key exclusion criteria (7 listed)
- tobacco user
- chronic disease, including diagnosed digestive disorders
- allergy or sensitivity to study product
- alcohol consumption within 24 hours of study visit
- caffeine consumption within 24 hours of study visit
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 |
|---|---|---|
| NAC1 375 mg capsule containing N-acetyl cysteine | Dietary supplement | NAC, Neuro-NAC XS, then Neuro-NAC, NAC, then neuro-NAC, then Neuro-NAC XS, Neuro-NAC XS, then NAC, then Neuro-NAC, Neuro-NAC XS, then Neuro-NAC, then NAC, Neuro-NAC, then NAC, then Neuro-NAC XS, Neuro-NAC, then Neuro-NAC XS, then NAC |
| Neuro-NAC3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester | Dietary supplement | NAC, Neuro-NAC XS, then Neuro-NAC, NAC, then neuro-NAC, then Neuro-NAC XS, Neuro-NAC XS, then NAC, then Neuro-NAC, Neuro-NAC XS, then Neuro-NAC, then NAC, Neuro-NAC, then NAC, then Neuro-NAC XS, Neuro-NAC, then Neuro-NAC XS, then NAC |
| Neuro-NAC XS3 capsules containing a total of 75 mcg Selenium, 150 mcg Molybdenum, 1800 mg Glycine, and 375 mg N-Acetyl L-Cysteine Ethyl Ester | Dietary supplement | NAC, Neuro-NAC XS, then Neuro-NAC, NAC, then neuro-NAC, then Neuro-NAC XS, Neuro-NAC XS, then NAC, then Neuro-NAC, Neuro-NAC XS, then Neuro-NAC, then NAC, Neuro-NAC, then NAC, then Neuro-NAC XS, Neuro-NAC, then Neuro-NAC XS, then NAC |
Primary outcome
Area under the concentration curve for glutathione
Time frame: 24 hour period following supplement ingestion
The area under the concentration curve for reduced glutathione over oxidized glutathione will be calculated for each supplement.
Terminal Half-life of glutathione
Time frame: 24 hour period following supplement ingestion
The terminal half-life of reduced glutathione over oxidized glutathione will be calculated for each supplement
Peak concentration of glutathione
Time frame: 24 hour period following supplement ingestion
The peak concentration of reduced glutathione over oxidized glutathione will be determined for each supplement
Time to maximum concentration
Time frame: 24 hour period following supplement ingestion
The time to reaching the maximum concentration of reduced glutathione over oxidized glutathione will be determined for each supplement
Lag time
Time frame: 24 hour period following supplement ingestion
The lag time of each supplement will be determined.
Apparent volume distribution during terminal elimination phase
Time frame: 24 hour period following supplement ingestion
The apparent volume distribution during terminal elimination phase will be determined for reduced glutathione over oxidized glutathione
Oral Clearance of glutathione
Time frame: 24 hour period following supplement ingestion
The oral clearance of each supplement will be determined.
20 secondary outcomes
Blood Malondialdehyde
Time frame: 0 min prior to supplement ingestion (baseline)
Blood Malondialdehyde
Time frame: 2 hours following supplement ingestion
Blood Malondialdehyde
Time frame: 4 hours following supplement ingestion
Blood Malondialdehyde
Time frame: 8 hours following supplement ingestion
Blood Malondialdehyde
Time frame: 24 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
Time frame: 0 min prior to supplement ingestion (baseline)
Blood Advanced Oxidation Protein Products
Time frame: 2 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
Time frame: 4 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
Time frame: 8 hours following supplement ingestion
Blood Advanced Oxidation Protein Products
Time frame: 24 hours following supplement ingestion
Brunel Mood Scale
Time frame: 0 min prior to supplement ingestion (baseline)
Brunel Mood Scale
Time frame: 2 hours following supplement ingestion
Brunel Mood Scale
Time frame: 4 hours following supplement ingestion
Brunel Mood Scale
Time frame: 8 hours following supplement ingestion
Brunel Mood Scale
Time frame: 24 hours following supplement ingestion
Subjective Feelings
Time frame: 0 min prior to supplement ingestion (baseline)
Subjective Feelings
Time frame: 2 hours following supplement ingestion
Subjective Feelings
Time frame: 4 hours following supplement ingestion
Subjective Feelings
Time frame: 8 hours following supplement ingestion
Subjective Feelings
Time frame: 24 hours following supplement ingestion
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 16 Dec 2024.
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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.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAC, Neuro-NAC and Neuro-NAC XS in people with Pharmacokinetics, run by University of Memphis 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 7 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 16 Dec 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Area under the concentration curve for glutathione (time frame: 24 hour period following supplement ingestion). The study lists 7 primary outcomes in all. 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 16 Dec 2024.