Bioavailability of PRUVIN® and Its Effects in Healthy Subjects (INDIGO)

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).

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

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
• 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.