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NCT06863935
A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
NA trial testing High-dose omega-3 PUFA supplementation in Dyslipidemia in 40 participants. Completed in 18 January 2025.
19 September 2024
Quick facts
| Lead sponsor | S.LAB (SOLOWAYS) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 10 May 2024 |
| Primary completion | 19 September 2024 |
| Estimated completion | 18 January 2025 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- High-dose omega-3 PUFA supplementation
- High-dose omega-3 PUFA supplementation
Conditions studied
- Dyslipidemia — all drugs for Dyslipidemia →
Sponsor
S.LAB (SOLOWAYS) — full company profile →
Who can join
Adults 18 to 75, any sex, with Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of high-dose omega-3 PUFA supplementation in patients with dyslipidemia who carry a specific "unfavorable" genetic variant in the FADS1/FADS2 gene cluster. The study will compare lipid profile improvements and inflammatory markers between two cohorts: (1) homozygous (or high- risk) carriers of the FADS1/FADS2 variants and (2) non-carriers (wild-type). Investigators hypothesize that individuals with these variants will show a more pronounced reduction in triglyceride levels and inflammatory markers following high-dose omega-3 supplementation due to their diminished endogenous synthesis of long-chain PUFAs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06863935
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other S.LAB (SOLOWAYS) trials
Trials by the same sponsor.
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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 NCT06863935 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by S.LAB (SOLOWAYS)
- Last refreshed: 7 March 2025
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/NCT06863935.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing