Pharmacokinetic Profile of N-Acetyl Cysteine in Self-reported Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Time to maximum concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Each treatment was assigned a letter and provided to subjects in a paper cup.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NAC, then neuro-NAC, then Neuro-NAC XS
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.
干预措施: Neuro-NAC (Dietary Supplement)
NAC, Neuro-NAC XS, then Neuro-NAC
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.
干预措施: Neuro-NAC (Dietary Supplement)
Neuro-NAC, then NAC, then Neuro-NAC XS
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.
干预措施: Neuro-NAC (Dietary Supplement)
Neuro-NAC, then NAC, then Neuro-NAC XS
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.
干预措施: Neuro-NAC XS (Dietary Supplement)
Neuro-NAC, then Neuro-NAC XS, then NAC
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.
干预措施: Neuro-NAC (Dietary Supplement)
Neuro-NAC XS, then Neuro-NAC, then NAC
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.
干预措施: Neuro-NAC (Dietary Supplement)
NAC, then neuro-NAC, then Neuro-NAC XS
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.
干预措施: Neuro-NAC XS (Dietary Supplement)
NAC, Neuro-NAC XS, then Neuro-NAC
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.
干预措施: Neuro-NAC XS (Dietary Supplement)
Neuro-NAC, then Neuro-NAC XS, then NAC
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.
干预措施: Neuro-NAC XS (Dietary Supplement)
Neuro-NAC XS, then NAC, then Neuro-NAC
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.
干预措施: Neuro-NAC (Dietary Supplement)
Neuro-NAC XS, then NAC, then Neuro-NAC
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.
干预措施: Neuro-NAC XS (Dietary Supplement)
Neuro-NAC XS, then Neuro-NAC, then NAC
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.
干预措施: Neuro-NAC XS (Dietary Supplement)
结局指标
主要结局
Time to maximum concentration
时间窗: 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
Area under the concentration curve for glutathione
时间窗: 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
时间窗: 24 hour period following supplement ingestion
The terminal half-life of reduced glutathione over oxidized glutathione will be calculated for each supplement
Lag time
时间窗: 24 hour period following supplement ingestion
The lag time of each supplement will be determined.
Peak concentration of glutathione
时间窗: 24 hour period following supplement ingestion
The peak concentration of reduced glutathione over oxidized glutathione will be determined for each supplement
Apparent volume distribution during terminal elimination phase
时间窗: 24 hour period following supplement ingestion
The apparent volume distribution during terminal elimination phase will be determined for reduced glutathione over oxidized glutathione
Oral Clearance of glutathione
时间窗: 24 hour period following supplement ingestion
The oral clearance of each supplement will be determined.
次要结局
- Brunel Mood Scale(24 hours following supplement ingestion)
- Blood Malondialdehyde(24 hours following supplement ingestion)
- Blood Advanced Oxidation Protein Products(24 hours following supplement ingestion)
- Subjective Feelings(24 hours following supplement ingestion)
研究者
Richard Bloomer
Dean of College of Health Sciences
University of Memphis