RecruitingPhase 1

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

United States30 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.

Timeframe: 12 months

Changes in baseline blood glutathione levels (µmol/l) in people with RHI due to GGC supplementation.

Timeframe: 12 months

Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation.

Timeframe: 12 months

Trial details

NCT IDNCT07050173

SponsorPravat Mandal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

Contact for this trial

Pravat K MANDAL, PHD

4126999561 mandalpk@pitt.edu

View on ClinicalTrials.gov More Repetitive Head Impacts trials

Plain-language summary

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.

Timeframe: 12 months

Changes in baseline blood glutathione levels (µmol/l) in people with RHI due to GGC supplementation.

Timeframe: 12 months

Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation.

Timeframe: 12 months