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Completed

NCT Number: NCT06252519

Pharmacokinetic Profile of N-Acetyl Cysteine

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NAC

Dietary Supplement

1 375 mg capsule containing N-acetyl cysteine

Neuro-NAC

Dietary Supplement

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

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Lag time

    Time frame: 24 hour period following supplement ingestion

    The lag time of each supplement will be determined.

  6. 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

  7. Oral Clearance of glutathione

    Time frame: 24 hour period following supplement ingestion

    The oral clearance of each supplement will be determined.

Secondary outcomes

  1. Blood Malondialdehyde

    Time frame: 0 min prior to supplement ingestion (baseline)

    The concentration of malondialdehyde in blood will be measured in millimoles per liter

  2. Blood Malondialdehyde

    Time frame: 2 hours following supplement ingestion

    The concentration of malondialdehyde in blood will be measured millimoles per liter

  3. Blood Malondialdehyde

    Time frame: 4 hours following supplement ingestion

    The concentration of malondialdehyde in blood will be measured millimoles per liter

  4. Blood Malondialdehyde

    Time frame: 8 hours following supplement ingestion

    The concentration of malondialdehyde in blood will be measured millimoles per liter

  5. Blood Malondialdehyde

    Time frame: 24 hours following supplement ingestion

    The concentration of malondialdehyde in blood will be measured millimoles per liter

  6. Blood Advanced Oxidation Protein Products

    Time frame: 0 min prior to supplement ingestion (baseline)

    The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter

  7. Blood Advanced Oxidation Protein Products

    Time frame: 2 hours following supplement ingestion

    The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter

  8. Blood Advanced Oxidation Protein Products

    Time frame: 4 hours following supplement ingestion

    The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter

  9. Blood Advanced Oxidation Protein Products

    Time frame: 8 hours following supplement ingestion

    The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter

  10. Blood Advanced Oxidation Protein Products

    Time frame: 24 hours following supplement ingestion

    The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter

  11. Brunel Mood Scale

    Time frame: 0 min prior to supplement ingestion (baseline)

    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.

  12. Brunel Mood Scale

    Time frame: 2 hours following supplement ingestion

    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.

  13. Brunel Mood Scale

    Time frame: 4 hours following supplement ingestion

    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.

  14. Brunel Mood Scale

    Time frame: 8 hours following supplement ingestion

    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.

  15. Brunel Mood Scale

    Time frame: 24 hours following supplement ingestion

    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.

  16. Subjective Feelings

    Time frame: 0 min prior to supplement ingestion (baseline)

    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)

  17. Subjective Feelings

    Time frame: 2 hours following supplement ingestion

    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)

  18. Subjective Feelings

    Time frame: 4 hours following supplement ingestion

    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)

  19. Subjective Feelings

    Time frame: 8 hours following supplement ingestion

    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)

  20. Subjective Feelings

    Time frame: 24 hours following supplement ingestion

    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)

Other outcomes

  1. Heart Rate

    Time frame: 0 min prior to supplement ingestion (baseline)

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  2. Heart Rate

    Time frame: 0.25 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  3. Heart Rate

    Time frame: 0.5 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  4. Heart Rate

    Time frame: 1 hour following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  5. Heart Rate

    Time frame: 1.5 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  6. Heart Rate

    Time frame: 2 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  7. Heart Rate

    Time frame: 4 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  8. Heart Rate

    Time frame: 6 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  9. Heart Rate

    Time frame: 8 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  10. Heart Rate

    Time frame: 24 hours following supplement ingestion

    Heart Rate will be assessed in beats per minute using an automated blood pressure cuff.

  11. Diastolic Blood Pressure

    Time frame: 0 min prior to supplement ingestion (baseline)

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  12. Diastolic Blood Pressure

    Time frame: 0.25 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  13. Diastolic Blood Pressure

    Time frame: 0.5 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  14. Diastolic Blood Pressure

    Time frame: 1 hour following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  15. Diastolic Blood Pressure

    Time frame: 1.5 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  16. Diastolic Blood Pressure

    Time frame: 2 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  17. Diastolic Blood Pressure

    Time frame: 4 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  18. Diastolic Blood Pressure

    Time frame: 6 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  19. Diastolic Blood Pressure

    Time frame: 8 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  20. Diastolic Blood Pressure

    Time frame: 24 hours following supplement ingestion

    Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  21. Systolic Blood Pressure

    Time frame: 0 min prior to supplement ingestion (baseline)

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  22. Systolic Blood Pressure

    Time frame: 0.25 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  23. Systolic Blood Pressure

    Time frame: 0.5 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  24. Systolic Blood Pressure

    Time frame: 1 hour following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  25. Systolic Blood Pressure

    Time frame: 1.5 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  26. Systolic Blood Pressure

    Time frame: 2 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  27. Systolic Blood Pressure

    Time frame: 4 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  28. Systolic Blood Pressure

    Time frame: 6 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  29. Systolic Blood Pressure

    Time frame: 8 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

  30. Systolic Blood Pressure

    Time frame: 24 hours following supplement ingestion

    Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Nature Fusions

Registry information

Official study title

Pharmacokinetic Profile of N-Acetyl Cysteine in Self-reported Healthy Men and Women

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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