Last reviewed · How we verify
NCT04150159
Evaluation of a Fasting Mimicking Diet
NA trial testing FMD Arm in Coronary Artery Disease in 80 participants. Completed in 31 January 2020.
31 January 2020
Quick facts
| Lead sponsor | Hypertension Institute, Nashville |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 1 March 2019 |
| Primary completion | 31 January 2020 |
| Estimated completion | 31 January 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- FMD Arm
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Hypertension Institute, Nashville
Who can join
Adults 35 to 75, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fasting-mimicking diet causes hepatic and blood markers changes indicating reduced biological age and disease risk.
Brandhorst S, Levine ME, Wei M, Shelehchi M, et al · · 2024 · cited 34× · PMID 38378685 · DOI 10.1038/s41467-024-45260-9 -
Guts for Self-Eating: Role of Autophagy in Gastrointestinal Health and Disease.
Nighot P, Stine J, Clarke K. · · 2025 · cited 2× · PMID 40487273 · DOI 10.1016/j.gastha.2025.100654 -
Fasting mimicking diet cycles versus a Mediterranean diet and cardiometabolic risk in overweight and obese hypertensive subjects: a randomized clinical trial.
Mishra A, Fanti M, Ge X, Vaughn D, et al · · 2023 · cited 1× · PMID 40604264 · DOI 10.1038/s44324-023-00002-1
Verify or expand the search:
- PubMed search for NCT04150159
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hypertension Institute, Nashville trials
Trials by the same sponsor.
- NCT03895749 — Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults · NA · completed
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 NCT04150159 (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 Hypertension Institute, Nashville
- Last refreshed: 31 July 2020
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/NCT04150159.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing