Pharmacokinetics
Conditions
Keywords
N-Acetyl Cysteine, N-Acetyl Cysteine Ethyl Ester
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.
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.
Interventions
DIETARY_SUPPLEMENTNAC
1 375 mg capsule containing N-acetyl cysteine
DIETARY_SUPPLEMENTNeuro-NAC
3 capsules containing a total of 375 mg N-Acetyl L-Cysteine Ethyl Ester
DIETARY_SUPPLEMENTNeuro-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
Sponsors
Nature Fusions
University of Memphis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Each treatment was assigned a letter and provided to subjects in a paper cup.
Intervention model description
Randomized cross-over single-blinded study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Clearance of glutathione | 24 hour period following supplement ingestion | The oral clearance of each supplement will be determined. |
| Area under the concentration curve for glutathione | 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 | 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 | 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 | 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 | 24 hour period following supplement ingestion | The lag time of each supplement will be determined. |
| Apparent volume distribution during terminal elimination phase | 24 hour period following supplement ingestion | The apparent volume distribution during terminal elimination phase will be determined for reduced glutathione over oxidized glutathione |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Malondialdehyde | 0 min prior to supplement ingestion (baseline) | The concentration of malondialdehyde in blood will be measured in millimoles per liter |
| Blood Advanced Oxidation Protein Products | 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 |
| Brunel Mood Scale | 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. |
| Subjective Feelings | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | 0 min prior to supplement ingestion (baseline) | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. |
| Systolic Blood Pressure | 0 min prior to supplement ingestion (baseline) | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. |
| Heart Rate | 0 min prior to supplement ingestion (baseline) | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. |
Countries
United States
Outcome results
None listed