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临床试验/NCT05041179
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:
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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
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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