Oxidative Stress
Conditions
Keywords
Glutathione
Brief summary
To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine \[NAC\] and glycine) on reduced glutathione levels in healthy elderly subjects
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).
Interventions
DIETARY_SUPPLEMENTPruvin R
Combination of N-acetylcysteine an glycine
OTHERIsomaltulose
Placebo as comparator to intervention
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, randomized, Placebo-controlled
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Non-interventional cohort: Inclusion criteria: 1. 20-40 years, both inclusive 2. male and female 3. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator. 4. BMI \>18.5 and \<30.0 kg/m2 5. HbA1c \<5.7 % 6. Informed consent as documented by signature
Exclusion criteria
1. Receipt of any medicinal product or nutritional product in clinical development within 30 days before enrollment in this trial. 2. Any history or presence of clinically relevant comorbidity, as judged by the Investigator. 3. Signs of acute illness as judged by the Investigator. 4. Any serious systemic infectious disease during four weeks prior enrollment in this trial 5. Clinically significant abnormal screening laboratory tests, as judged by the Investigator. 6. AST and/or ALT \> 2 times the upper limit of normal. 7. Elevated serum creatinine values above the upper limit of normal. 8. 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). 9. Heart rate at rest outside the range of 50-90 beats per minute. 10. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator. 11. 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. 12. Smoking or use of nicotine substitute products. 13. Any medication (prescription and non-prescription drugs) within 14 days before screening. 14. Blood donation or blood loss of more than 500 mL within the last 3 months prior to screening. 15. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 16. If female, pregnant or breast-feeding. 17. Consumption of high protein supplements within 60 days of screening and during the study. 18. 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: 1. 60-85 years, both inclusive 2. male and female 3. Sedentary, less than 1h of strenuous physical exercise per week 4. BMI of 25.0 to 35.0 kg/m2, both inclusive 5. HbA1c\<6.5 % 6. Informed consent as documented by signature
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total reduced glutathione | 2 weeks | Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed