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

Nestlé

Status: Completed

Conditions: Oxidative Stress

Treatments: Dietary Supplement: Pruvin R; Other: Isomaltulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05041179

18.01.CLI

Details and patient eligibility

About

To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine [NAC] and glycine) on reduced glutathione levels in healthy elderly subjects

Full 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).

Enrollment: 128 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

1. Known or suspected hypersensitivity to any component of the trial products.
2. Receipt of any medicinal product or nutritional product in clinical development within 30 days before randomisation in this trial.
3. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
4. Any history or presence of clinically relevant comorbidity, as judged by the Investigator.
5. Signs of acute illness as judged by the Investigator.
6. Any serious systemic infectious disease during four weeks prior to first intake of the trial product, as judged by the Investigator.
7. Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
8. AST and/or ALT > 2 times the upper limit of normal.
9. Elevated serum creatinine values above the upper limit of normal.
10. 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).
11. Heart rate at rest outside the range of 50-90 beats per minute.
12. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
13. 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.
14. Smoking more than 5 cigarettes or the equivalent per day.
15. Inability or unwillingness to refrain from smoking and use of nicotine substitute products 3 days prior and during the intervention.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

7.2 g of actives (3.6 g NAC and 3.6 g glycine) per day split in two doses (arm A)

Active Comparator group

Description:

* 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

Treatment:

Dietary Supplement: Pruvin R

4.8 g of actives (2.4 g NAC and 2.4 g glycine) per day split in two doses (arm B)

Active Comparator group

Description:

* 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

Treatment:

Dietary Supplement: Pruvin R

2.4 g of actives (1.2 g NAC and 1.2 g glycine) per day split in two doses (arm C)

Active Comparator group

Description:

* 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

Treatment:

Dietary Supplement: Pruvin R

Placebo control (7.2 g isomaltulose)(arm D)

Placebo Comparator group

Description:

* First dose (3.6 g isomaltulose) consumed in the morning * Second dose (3.6 g isomaltulose) taken in the evening

Treatment:

Other: Isomaltulose