Bioavailability of PRUVIN® and Its Effects in Healthy Subjects (INDIGO)
Study Details
Study Description
Brief Summary
To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine [NAC] and glycine) on reduced glutathione levels in healthy elderly subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 7.2 g of actives (3.6 g NAC and 3.6 g glycine) per day split in two doses (arm A) 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 |
Dietary Supplement: Pruvin R
Combination of N-acetylcysteine an glycine
|
| Active Comparator: 4.8 g of actives (2.4 g NAC and 2.4 g glycine) per day split in two doses (arm B) 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 |
Dietary Supplement: Pruvin R
Combination of N-acetylcysteine an glycine
|
| Active Comparator: 2.4 g of actives (1.2 g NAC and 1.2 g glycine) per day split in two doses (arm C) 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 |
Dietary Supplement: Pruvin R
Combination of N-acetylcysteine an glycine
|
| Placebo Comparator: Placebo control (7.2 g isomaltulose)(arm D) First dose (3.6 g isomaltulose) consumed in the morning Second dose (3.6 g isomaltulose) taken in the evening |
Other: Isomaltulose
Placebo as comparator to intervention
|
Outcome Measures
Primary Outcome Measures
- Total reduced glutathione [2 weeks]
Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit
Secondary Outcome Measures
- Free reduced glutathione [2 weeks]
Free reduced glutathione (GSH-F), free reduced glutathione to oxidized glutathione disulfide ratio (GSH-F:GSSG)
- Hematocrit [2 weeks]
Whole-blood concentrations of glycine and cysteine normalized to hematocrit
- Lipid oxidation [2 weeks]
Lipid oxidation derived from indirect calorimetry
Eligibility Criteria
Criteria
Non-interventional cohort:
Inclusion criteria:
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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
Exclusion criteria:
-
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
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Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
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AST and/or ALT > 2 times the upper limit of normal.
-
Elevated serum creatinine values above the upper limit of normal.
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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.
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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.
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Smoking or use of nicotine substitute products.
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Any medication (prescription and non-prescription drugs) within 14 days before screening.
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Blood donation or blood loss of more than 500 mL within the last 3 months prior to screening.
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Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
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If female, pregnant or breast-feeding.
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Consumption of high protein supplements within 60 days of screening and during the study.
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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
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Sedentary, less than 1h of strenuous physical exercise per week
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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.
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Receipt of any medicinal product or nutritional product in clinical development within 30 days before randomisation in this trial.
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History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Profil Institut für Stoffwechselforschung GmbH | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Nestlé
Investigators
- Principal Investigator: Ulrike Hövelmann, MD, Profil Institut für Stoffwechselforschung GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18.01.CLI