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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05041179
Other study ID # 18.01.CLI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date May 1, 2020

Study information

Verified date August 2021
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date May 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Pruvin R
Combination of N-acetylcysteine an glycine
Other:
Isomaltulose
Placebo as comparator to intervention

Locations

Country Name City State
Germany Profil Institut für Stoffwechselforschung GmbH Neuss

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total reduced glutathione Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit 2 weeks
Secondary Free reduced glutathione Free reduced glutathione (GSH-F), free reduced glutathione to oxidized glutathione disulfide ratio (GSH-F:GSSG) 2 weeks
Secondary Hematocrit Whole-blood concentrations of glycine and cysteine normalized to hematocrit 2 weeks
Secondary Lipid oxidation Lipid oxidation derived from indirect calorimetry 2 weeks
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