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| Name | Class |
|---|---|
| Nature Fusions | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAC | Dietary Supplement | 1 375 mg capsule containing N-acetyl cysteine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Malondialdehyde | The concentration of malondialdehyde in blood will be measured in millimoles per liter | 0 min prior to supplement ingestion (baseline) |
| Blood Malondialdehyde | The concentration of malondialdehyde in blood will be measured millimoles per liter |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 0 min prior to supplement ingestion (baseline) |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bloomer, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Memphis | Tennessee | 38152 | United States |
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Randomized cross-over single-blinded study
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Each treatment was assigned a letter and provided to subjects in a paper cup.
|
| 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. |
|
| 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. |
|
| 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 |
|
The oral clearance of each supplement will be determined.
| 24 hour period following supplement ingestion |
| 2 hours following supplement ingestion |
| Blood Malondialdehyde | The concentration of malondialdehyde in blood will be measured millimoles per liter | 4 hours following supplement ingestion |
| Blood Malondialdehyde | The concentration of malondialdehyde in blood will be measured millimoles per liter | 8 hours following supplement ingestion |
| Blood Malondialdehyde | The concentration of malondialdehyde in blood will be measured millimoles per liter | 24 hours following supplement ingestion |
| Blood Advanced Oxidation Protein Products | The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter | 0 min prior to supplement ingestion (baseline) |
| Blood Advanced Oxidation Protein Products | The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter | 2 hours following supplement ingestion |
| Blood Advanced Oxidation Protein Products | The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter | 4 hours following supplement ingestion |
| Blood Advanced Oxidation Protein Products | The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter | 8 hours following supplement ingestion |
| Blood Advanced Oxidation Protein Products | The concentration of blood advanced oxidation protein products will be measured in units of micromoles Chloramine per liter | 24 hours following supplement ingestion |
| Brunel Mood Scale | 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. | 0 min prior to supplement ingestion (baseline) |
| Brunel Mood Scale | 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. | 2 hours following supplement ingestion |
| Brunel Mood Scale | 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. | 4 hours following supplement ingestion |
| Brunel Mood Scale | 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. | 8 hours following supplement ingestion |
| Brunel Mood Scale | 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. | 24 hours following supplement ingestion |
| Subjective Feelings | 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) | 0 min prior to supplement ingestion (baseline) |
| Subjective Feelings | 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) | 2 hours following supplement ingestion |
| Subjective Feelings | 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) | 4 hours following supplement ingestion |
| Subjective Feelings | 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) | 8 hours following supplement ingestion |
| Subjective Feelings | 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) | 24 hours following supplement ingestion |
| 0.25 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 0.5 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 1 hour following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 1.5 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 2 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 4 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 6 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 8 hours following supplement ingestion |
| Heart Rate | Heart Rate will be assessed in beats per minute using an automated blood pressure cuff. | 24 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 0 min prior to supplement ingestion (baseline) |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 0.25 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 0.5 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 1 hour following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 1.5 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 2 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 4 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 6 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 8 hours following supplement ingestion |
| Diastolic Blood Pressure | Diastolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 24 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 0 min prior to supplement ingestion (baseline) |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 0.25 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 0.5 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 1 hour following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 1.5 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 2 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 4 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 6 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 8 hours following supplement ingestion |
| Systolic Blood Pressure | Systolic blood pressure will be assessed in millimeters mercury using an automated blood pressure cuff. | 24 hours following supplement ingestion |