NCT05041179已完成不适用
Investigation on the Bioavailability of PRUVIN® and Its Effects on Physiologic-metabolic Biomarkers in Healthy Subjects
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Total reduced glutathione
研究概览
简要总结
To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine [NAC] and glycine) on reduced glutathione levels in healthy elderly subjects
详细描述
This is a single-center, double-blind, randomized, placebo-controlled 4-arm study-design, to assess the safety, tolerability and effect of PRUVIN® on reduced glutathione levels in healthy elderly (age 60-85 years) subjects.
In addition, baseline values of glutathione precursors, glutathione, and plasma markers of oxidative stress in a healthy young cohort (non-interventional) will be compared with those of the healthy elderly cohort (interventional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-interventional cohort:
- •Inclusion criteria:
- •20-40 years, both inclusive
- •male and female
- •Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
- •BMI >18.5 and <30.0 kg/m2
- •HbA1c <5.7 %
- •Informed consent as documented by signature
排除标准
- •Receipt of any medicinal product or nutritional product in clinical development within 30 days before enrollment in this trial.
- •Any history or presence of clinically relevant comorbidity, as judged by the Investigator.
- •Signs of acute illness as judged by the Investigator.
- •Any serious systemic infectious disease during four weeks prior enrollment in this trial
- •Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
- •AST and/or ALT > 2 times the upper limit of normal.
- •Elevated serum creatinine values above the upper limit of normal.
- •Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or >89 mmHg (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
- •Heart rate at rest outside the range of 50-90 beats per minute.
- •Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
- •Significant history of alcoholism or drug abuse as judged by the Investigator consuming more than 24 grams alcohol/day (for males), 12 grams alcohol/day (for females) on average.
- •Smoking or use of nicotine substitute products.
- •Any medication (prescription and non-prescription drugs) within 14 days before screening.
- •Blood donation or blood loss of more than 500 mL within the last 3 months prior to screening.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- •If female, pregnant or breast-feeding.
- •Consumption of high protein supplements within 60 days of screening and during the study.
- •Consumption of any antioxidant, vitamins, and herbals (see chapter 12.2) supplements within 2 weeks prior to screening and during the study.
- •Interventional Cohort:
- •Inclusion Criteria:
- •60-85 years, both inclusive
- •male and female
- •Sedentary, less than 1h of strenuous physical exercise per week
- •BMI of 25.0 to 35.0 kg/m2, both inclusive
- •HbA1c<6.5 %
- •Informed consent as documented by signature
- •Exclusion Criteria:
- •Known or suspected hypersensitivity to any component of the trial products.
- •Receipt of any medicinal product or nutritional product in clinical development within 30 days before randomisation in this trial.
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- •Any history or presence of clinically relevant comorbidity, as judged by the Investigator.
- •Signs of acute illness as judged by the Investigator.
- •Any serious systemic infectious disease during four weeks prior to first intake of the trial product, as judged by the Investigator.
- •Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
- •AST and/or ALT > 2 times the upper limit of normal.
- •Elevated serum creatinine values above the upper limit of normal.
- •Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or >89 mmHg (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
- •Heart rate at rest outside the range of 50-90 beats per minute.
- •Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
- •Significant history of alcoholism or drug abuse as judged by the Investigator consuming more than 24 grams alcohol/day (for males), 12 grams alcohol/day (for females) on average.
- •Smoking more than 5 cigarettes or the equivalent per day.
- •Inability or unwillingness to refrain from smoking and use of nicotine substitute products 3 days prior and during the intervention.
研究组 & 干预措施
7.2 g of actives (3.6 g NAC and 3.6 g glycine) per day split in two doses (arm A)
Active Comparator
- First dose (1.8 g NAC and 1.8 g glycine) consumed in the morning
- Second dose (1.8 g NAC and 1.8 g glycine) taken in the evening
干预措施: Pruvin R (Dietary Supplement)
4.8 g of actives (2.4 g NAC and 2.4 g glycine) per day split in two doses (arm B)
Active Comparator
- First dose (1.2 g NAC and 1.2 g glycine, +1.2 g placebo) consumed in the morning
- Second dose (1.2 g NAC and 1.2 g glycine, +1.2 g placebo) taken in the evening
干预措施: Pruvin R (Dietary Supplement)
2.4 g of actives (1.2 g NAC and 1.2 g glycine) per day split in two doses (arm C)
Active Comparator
- First dose (0.6 g NAC and 0.6 g glycine, +2.4 g placebo) consumed in the morning
- Second dose (0.6 g NAC and 0.6 g glycine, +2.4 g placebo) taken in the evening
干预措施: Pruvin R (Dietary Supplement)
Placebo control (7.2 g isomaltulose)(arm D)
Placebo Comparator
- First dose (3.6 g isomaltulose) consumed in the morning
- Second dose (3.6 g isomaltulose) taken in the evening
干预措施: Isomaltulose (Other)
结局指标
主要结局
Total reduced glutathione
时间窗: 2 weeks
Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit
次要结局
- Free reduced glutathione(2 weeks)
- Hematocrit(2 weeks)
- Lipid oxidation(2 weeks)
研究者
研究点 (1)
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