Oxidative StressNCT05041179
Bioavailability of PRUVIN® and Its Effects in Healthy Subjects (INDIGO)
A study testing Pruvin R and Isomaltulose in people with Oxidative Stress, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine [NAC] and glycine) on reduced glutathione levels in healthy elderly subjects Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Pruvin R and Isomaltulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Bioavailability of PRUVIN® and Its Effects on Physiologic-metabolic Biomarkers in Healthy Subjects
To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine [NAC] and glycine) on reduced glutathione levels in healthy elderly subjects
Read the 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).
- Conditions
- Oxidative Stress
- Being tested
- Pruvin R, Isomaltulose
- Keywords
- Glutathione
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pruvin RDietary supplement
Combination of N-acetylcysteine an glycine
IsomaltuloseOther
Placebo as comparator to intervention
| Study group | Role | What they receive |
|---|---|---|
| 7.2 g of actives (3.6 g NAC and 3.6 g glycine) per day split in two doses (arm A) | Active comparator | * 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 Receives: 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 | * 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 Receives: 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 | * 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 Receives: Dietary Supplement: Pruvin R |
| Placebo control (7.2 g isomaltulose)(arm D) | Placebo comparator | * First dose (3.6 g isomaltulose) consumed in the morning
* Second dose (3.6 g isomaltulose) taken in the evening Receives: Other: Isomaltulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total reduced glutathione
Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit
Measured: 2 weeks
Secondary outcomes (3)
Free reduced glutathione
Free reduced glutathione (GSH-F), free reduced glutathione to oxidized glutathione disulfide ratio (GSH-F:GSSG)
Measured: 2 weeks
Hematocrit
Whole-blood concentrations of glycine and cysteine normalized to hematocrit
Measured: 2 weeks
Lipid oxidation
Lipid oxidation derived from indirect calorimetry
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Hövelmann, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041179
- Sponsor's protocol ID
- 18.01.CLI
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lizzo G, Migliavacca E, Lamers D, Frezal A, Corthesy J, Vinyes-Pares G, Bosco N, Karagounis LG, Hovelmann U, Heise T, von Eynatten M, Gut P. A Randomized Controlled Clinical Trial in Healthy Older Adults to Determine Efficacy of Glycine and N-Acetylcysteine Supplementation on Glutathione Redox Status and Oxidative Damage. Front Aging. 2022 Mar 7;3:852569. doi: 10.3389/fragi.2022.852569. eCollection 2022.
PubMed 35821844
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Bioavailability of PRUVIN® and Its Effects on Physiologic-metabolic Biomarkers in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05041179
- Acronym / sponsor ID
- 18.01.CLI
- Conditions
- Oxidative Stress
- Keywords
- Glutathione
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind, randomized, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| 7.2 g of actives (3.6 g NAC and 3.6 g glycine) per day split in two doses (arm A) | Active comparator | Dietary Supplement: Pruvin R* 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 |
| 4.8 g of actives (2.4 g NAC and 2.4 g glycine) per day split in two doses (arm B) | Active comparator | Dietary Supplement: Pruvin R* 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 |
| 2.4 g of actives (1.2 g NAC and 1.2 g glycine) per day split in two doses (arm C) | Active comparator | Dietary Supplement: Pruvin R* 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 |
| Placebo control (7.2 g isomaltulose)(arm D) | Placebo comparator | Other: Isomaltulose* First dose (3.6 g isomaltulose) consumed in the morning * Second dose (3.6 g isomaltulose) taken in the evening |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 %
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pruvin RCombination of N-acetylcysteine an glycine | Dietary supplement | 2.4 g of actives (1.2 g NAC and 1.2 g glycine) per day split in two doses (arm C), 4.8 g of actives (2.4 g NAC and 2.4 g glycine) per day split in two doses (arm B), 7.2 g of actives (3.6 g NAC and 3.6 g glycine) per day split in two doses (arm A) |
| IsomaltulosePlacebo as comparator to intervention | Other | Placebo control (7.2 g isomaltulose)(arm D) |
Primary outcome
Total reduced glutathione
Time frame: 2 weeks
Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit
3 secondary outcomes
Free reduced glutathione
Time frame: 2 weeks
Hematocrit
Time frame: 2 weeks
Lipid oxidation
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 35821844Lizzo G, Migliavacca E, Lamers D, Frezal A, Corthesy J, Vinyes-Pares G, Bosco N, Karagounis LG, Hovelmann U, Heise T, von Eynatten M, Gut P. A Randomized Controlled Clinical Trial in Healthy Older Adults to Determine Efficacy of Glycine and N-Acetylcysteine Supplementation on Glutathione Redox Status and Oxidative Damage. Front Aging. 2022 Mar 7;3:852569. doi: 10.3389/fragi.2022.852569. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Hövelmann, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pruvin R and Isomaltulose in people with Oxidative Stress, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total reduced glutathione (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.