Recruiting
Phase 1

GGC

Sponsor:

Pravat Mandal

Code:

NCT07050173

Conditions

Repetitive Head Impacts

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Not accepted

Interventions

Gamma-glutamylcysteine (GGC)

Study Details

Brief summary:

The goal of this clinical trial is to test whether the gamma - glutamylcystiene (GGC) oral supplement can reach the brain and subsequently increase antioxidant glutathione (GSH) level in people with repetitive head impact (RHI). This will reduce the oxidative stress related injury in people with RHI.This unique study's main objective is to test the:

1. Change in GSH in brain and blood levels through GGC supplementation.
2. Change in the cognitive function in RHI patients due to GGC supplementation.

Conditions

Repetitive Head Impacts

Study ID

NCT07050173

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 27, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Retired NFL player, retired Navy SEAL/army personnel with combat experience exposed to repetitive head impact;
  • Memory and behavioral complaint per self- or informant-report;
  • Age (30 to 70 years of age) years;
  • Able to read and write in English and to give consent to participate in the study.

Exclusion Criteria:

  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.
  • Subjects with claustrophobia.
  • Subject with mild cognitive impairment \[TICS score of 29 or lower OR >=1.0 standard deviations below age-expectation on at least two cognitive members within the same cognitive domain (e.g. memory, attention, etc.) on the baseline neuropsychological testing;
  • Subjects with a history of cancer;
  • Subjects with active psychosis or delirium;
  • Subjects with chronic kidney (creatinine > 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥1.5 ULN) within 30 days prior to enrollment;
  • Subjects on antioxidant therapy (gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl;
  • Repeated head injury patients with neurosurgical intervention and;
  • Subjects with repeated head injury within the last 90 days.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Gamma - Glutamylcystiene

Each participant will receive gamma-glutamyl cysteine (GGC) tablet orally 400mg (two times) per day once in the morning and once in the evening for 12 months.

Interventions

Gamma-glutamylcysteine (GGC)

400mg tablet orally (two times) per day.

Primary outcome measure

  • Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation. [ Time Frame: 12 months ]
  • Changes in baseline blood glutathione levels (µmol/l) in people with RHI due to GGC supplementation. [ Time Frame: 12 months ]
  • Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Pravat K MANDAL, PHD

4126999561mandalpk@pitt.edu

Locations

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Pravat K Mandal, PhD

412-699-9561mandalpk@pitt.edu

Nazia Pillar, Ms

8573702614naa430@pitt.edu

Principal Investigator:

Pravat K Mandal, PhD

More Information

Sponsor

Pravat Mandal

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Brain injury
  • Glutathione
  • MR spectroscopy
  • Non- invasive
  • GGC
  • RHI
  • TES
  • Brain
  • Blood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pravat Mandal on 2026-06-03.