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

NCT05041179 | Completed

• 1 other identifier: 18.01.CLI
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oxidative Stress

Keywords

Glutathione

Outcome Measures

Primary Outcomes (1)

• Total reduced glutathione

  Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit

  2 weeks

Secondary Outcomes (3)

• Free reduced glutathione

  2 weeks

• Hematocrit

  2 weeks

• Lipid oxidation

  2 weeks

Study Arms (4)

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

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

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

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

Other: Isomaltulose

Interventions

Pruvin R DIETARY_SUPPLEMENT

Combination of N-acetylcysteine an glycine

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)

Isomaltulose OTHER

Placebo as comparator to intervention

Placebo control (7.2 g isomaltulose)(arm D)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• 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.

  PMID: 35821844 DERIVED

MeSH Terms

Interventions

isomaltulose

Study Officials

• Ulrike Hövelmann, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, Placebo-controlled

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)