Pharmacokinetic Profile of N-Acetyl Cysteine

NCT06252519 | Completed

• 1 other identifier: PRO-FY2023-417
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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, 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

Keywords

N-Acetyl Cysteine; N-Acetyl Cysteine Ethyl Ester

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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

  24 hour period following supplement ingestion

• Lag time

  The lag time of each supplement will be determined.

  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

  24 hour period following supplement ingestion

• Oral Clearance of glutathione

  The oral clearance of each supplement will be determined.

  24 hour period following supplement ingestion

Secondary Outcomes (20)

• Blood Malondialdehyde

  0 min prior to supplement ingestion (baseline)

• Blood Malondialdehyde

  2 hours following supplement ingestion

• Blood Malondialdehyde

  4 hours following supplement ingestion

• Blood Malondialdehyde

  8 hours following supplement ingestion

• Blood Malondialdehyde

  24 hours following supplement ingestion

Other Outcomes (30)

• Heart Rate

  0 min prior to supplement ingestion (baseline)

• Heart Rate

  0.25 hours following supplement ingestion

• Heart Rate

  0.5 hours following supplement ingestion

Study Arms (6)

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.

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.

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.

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.

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.

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.

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

Interventions

NAC DIETARY_SUPPLEMENT

1 375 mg capsule containing N-acetyl cysteine

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 DIETARY_SUPPLEMENT

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

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 XS 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; 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Memphis: lead
• Nature Fusions: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each treatment was assigned a letter and provided to subjects in a paper cup.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of College of Health Sciences

Model Details: Randomized cross-over single-blinded study

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: September 18, 2023
• Primary Completion: December 13, 2023
• Study Completion: May 22, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (1)