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NCT05439590
Impact of Cottonseed Oil on Oxidative Stress, Inflammation, and Metabolism
NA trial testing High dose CSO in Inflammation in 47 participants. Completed in 3 November 2023.
3 November 2023
Quick facts
| Lead sponsor | Montana State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 47 |
| Start date | 8 August 2022 |
| Primary completion | 3 November 2023 |
| Estimated completion | 3 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- High dose CSO
- Low dose CSO
- Low dose OO
- High dose OO
Conditions studied
- Inflammation — all drugs for Inflammation →
- Healthy — all drugs for Healthy →
- Oxidative Stress — all drugs for Oxidative Stress →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
Montana State University
Who can join
Adults 18 to 55, any sex, with Inflammation or Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recent research evidence suggests that cottonseed oil (CSO) may have both direct and indirect anti-inflammatory and anti-oxidative impacts linked to bioactive components of CSO and favorable alterations in lipid metabolism. These impacts are directly related to non-communicable diseases such as diabetes, cardiovascular diseases, and cancer. Our overarching hypothesis is that the effect of CSO consumption on oxidative stress markers (isoprostanes), inflammatory cytokines, metabolic biomarkers, and bile acid metabolism will be beneficial for reversing disease pathophysiology linked to oxidative stress, inflammation, and bile acids. Our long-term goal is to establish effective and practical therapeutic strategies utilizing dietary incorporation of CSO to prevent or reverse these diseases. The following hypotheses will be tested in the proposed investigation: H1: CSO consumption will lower exercise-induced oxidative stress, and the effect of CSO will be greater than that of OO for lowering of exercise-induced oxidative stress. H2: CSO consumption will lower inflammatory cytokines and metabolic markers linked to the inflammation process in human participants, and the effect of CSO will be greater than that of OO for lowering inflammation. H3: Features of serum bile acids, serum metabolomes, and lipidomes distinguishing CSO and OO treatment correspond to metabolic pathways illuminating the health benefits of CSO treatment. H4: Metabolic and inflammatory impacts of dietary oils will be greater for 60 g/d of CSO compared to 30 g/d.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dietary Intervention with Cottonseed and Olive Oil Differentially Affect the Circulating Lipidome and Immunoregulatory Compounds-A Randomized Clinical Trial.
Cooper G, Bhattarai P, Sather B, Bailey ML, et al · · 2025 · PMID 41002983 · DOI 10.3390/metabo15090599
Verify or expand the search:
- PubMed search for NCT05439590
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05439590 (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 Montana State University
- Last refreshed: 18 November 2023
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/NCT05439590.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing