Pharmacokinetic Profile of N-Acetyl Cysteine

University of Memphis

Status: Completed

Conditions: Pharmacokinetics

Treatments: Dietary Supplement: Neuro-NAC XS; Dietary Supplement: Neuro-NAC; Dietary Supplement: NAC

Study type: Interventional

Funder types: Other

Identifiers

NCT06252519

PRO-FY2023-417

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 6 patient groups

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: NAC

Dietary Supplement: Neuro-NAC

Dietary Supplement: Neuro-NAC XS

NAC, Neuro-NAC XS, then Neuro-NAC

Experimental group

Description:

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.

Treatment:

Dietary Supplement: NAC

Dietary Supplement: Neuro-NAC

Dietary Supplement: Neuro-NAC XS

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: NAC

Dietary Supplement: Neuro-NAC

Dietary Supplement: Neuro-NAC XS

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: NAC

Dietary Supplement: Neuro-NAC

Dietary Supplement: Neuro-NAC XS

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: NAC

Dietary Supplement: Neuro-NAC

Dietary Supplement: Neuro-NAC XS

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: NAC

Dietary Supplement: Neuro-NAC

Dietary Supplement: Neuro-NAC XS