Who is sponsoring NCT05138198?

NCT05138198 is sponsored by Stony Brook University.

What drugs are being tested in NCT05138198?

Interventions in NCT05138198: Mediterranean Diet & Physical Activity, Usual Care.

What condition does NCT05138198 study?

NCT05138198 studies Post-Traumatic Stress Disorder, Overweight and Obesity, Metabolic Syndrome, Inflammation.

Is NCT05138198 still recruiting?

NCT05138198 is currently status unknown. Last updated 30 November 2021.

Last reviewed 2021-11-30 · How we verify

NCT05138198

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders

Status unknown NA Last updated 30 November 2021

What this trial tests

NA trial testing Mediterranean Diet & Physical Activity in Post-Traumatic Stress Disorder in 62 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Stony Brook University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	62
Start date	1 December 2020
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across United States

Drugs / interventions tested

Mediterranean Diet & Physical Activity
Usual Care

Conditions studied

Post-Traumatic Stress Disorder — all drugs for Post-Traumatic Stress Disorder →
Overweight and Obesity — all drugs for Overweight and Obesity →
Metabolic Syndrome — all drugs for Metabolic Syndrome →
Inflammation — all drugs for Inflammation →

Sponsor

Stony Brook University

Who can join

Adults 40 to 65, any sex, with Post-Traumatic Stress Disorder or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomized control trial (RCT) is to test the feasibility and acceptability of a lifestyle intervention with a focus on implementing a high dose Mediterranean Diet protocol with physical activity to reduce systemic inflammation and body weight among WTC first responders having overweight/obesity and PTSD. The findings of this study will demonstrate the suitability of the proposed approach to reduce comorbidities among similar populations exposed to traumatic events; the findings will also inform the World Trade Center Health Program's extensive research and clinical efforts with the potential to provide a preventive care model to reduce systemic inflammation and related chronic disease among WTC responders with PTSD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Mediterranean diet intervention among World Trade Center responders with post-traumatic stress disorder: Feasibility and outcomes of a pilot randomized controlled trial.
Arcan C, Hou W, Hoffman K, Reichardt A, et al · · 2024 · cited 7× · PMID 38263989 · DOI 10.1002/osp4.725

Verify or expand the search:

Other Stony Brook University trials

Trials by the same sponsor.

NCT07478250 — First Responder Safety Training (FiRST) · NA · not yet recruiting
NCT07076342 — The Role of mGluR5 in CBT-I · Phase 4 · recruiting
NCT07009691 — Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS · NA · recruiting
NCT07114900 — Randomized Controlled Physical Activity App Intervention for Black Women · Phase 3 · active not recruiting
NCT05245227 — Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05138198 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stony Brook University
Last refreshed: 30 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05138198.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing