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Pharmacokinetic Profile of N-Acetyl Cysteine

NCT ID: NCT06252519

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-05-22

Brief Summary

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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

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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

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Pharmacokinetics

Keywords

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N-Acetyl Cysteine N-Acetyl Cysteine Ethyl Ester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over single-blinded study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Each treatment was assigned a letter and provided to subjects in a paper cup.

Study Groups

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NAC, then neuro-NAC, then Neuro-NAC XS

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.

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Intervention Type DIETARY_SUPPLEMENT

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Neuro-NAC XS

Intervention Type DIETARY_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

NAC, Neuro-NAC XS, then Neuro-NAC

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.

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Intervention Type DIETARY_SUPPLEMENT

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Neuro-NAC XS

Intervention Type DIETARY_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

Neuro-NAC, then NAC, then Neuro-NAC XS

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.

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Intervention Type DIETARY_SUPPLEMENT

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Neuro-NAC XS

Intervention Type DIETARY_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

Neuro-NAC, then Neuro-NAC XS, then NAC

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.

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Intervention Type DIETARY_SUPPLEMENT

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Neuro-NAC XS

Intervention Type DIETARY_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

Neuro-NAC XS, then NAC, then Neuro-NAC

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.

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Intervention Type DIETARY_SUPPLEMENT

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Neuro-NAC XS

Intervention Type DIETARY_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

Neuro-NAC XS, then Neuro-NAC, then NAC

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.

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Intervention Type DIETARY_SUPPLEMENT

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Neuro-NAC XS

Intervention Type DIETARY_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

Interventions

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NAC

1 375 mg capsule containing N-acetyl cysteine

Intervention Type DIETARY_SUPPLEMENT

Neuro-NAC

3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester

Intervention Type DIETARY_SUPPLEMENT

Neuro-NAC XS

3 capsules containing a total of 75 mcg Selenium, 150 mcg Molybdenum, 1800 mg Glycine, and 375 mg N-Acetyl L-Cysteine Ethyl Ester

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nature Fusions

UNKNOWN

Sponsor Role collaborator

University of Memphis

OTHER

Sponsor Role lead

Responsible Party

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Richard Bloomer

Dean of College of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

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Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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PRO-FY2023-417

Identifier Type: -

Identifier Source: org_study_id