Last reviewed · How we verify
NCT04190706: SINFONI
Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention
NA trial testing bioactive components fortified food products intake (biscuits and cookies) in Cardiometabolic Risk in 62 participants. Completed in 17 May 2022.
17 May 2022
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 62 |
| Start date | 21 January 2020 |
| Primary completion | 17 May 2022 |
| Estimated completion | 17 May 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- bioactive components fortified food products intake (biscuits and cookies)
- control food products intake (biscuits and cookies)
Conditions studied
- Cardiometabolic Risk — all drugs for Cardiometabolic Risk →
- Abdominal Obesity — all drugs for Abdominal Obesity →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 30 to 65, any sex, with Cardiometabolic Risk or Abdominal Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to evaluate the synergistic effects of daily consumption of food products fortified with bioactive components (fibres, polyphenols, omega-3, Slow Digestible Starch) for 9 weeks, compared to the daily intake of standard food products on low-grade inflammation in cardiometabolic risk subject. The inflammatory parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A metabolic stress will be induced by a fructose ingestion challenge during the last 6 days of interventional period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Multifunctional dietary approach reduces intestinal inflammation in relation with changes in gut microbiota composition in subjects at cardiometabolic risk: the SINFONI project.
Hornero-Ramirez H, Morisette A, Marcotte B, Penhoat A, et al · · 2025 · cited 14× · PMID 39710576 · DOI 10.1080/19490976.2024.2438823
Verify or expand the search:
- PubMed search for NCT04190706
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiometabolic Risk
Currently open trials in the same condition.
- NCT07103343 — MOVI-OLE! [Open Learning Environments] · NA · active not recruiting
- NCT07114991 — E-Bike Commuting and Health in Overweight College Students · NA · active not recruiting
- NCT06538831 — Impact of Ultra-processed Foods on Cardiometabolic Risk Factors · NA · recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting
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 NCT04190706 (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 Hospices Civils de Lyon
- Last refreshed: 25 September 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/NCT04190706.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing