Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment
A single-arm phase 1/2 trial in 90 cancer patients at low nutritional risk undergoing active treatment.
Cancers (Basel), 2021. Valdemarin F, et al.
Funding and competing interests (from the paper, shortened): A. Nencioni and I. Caffa are inventors on patents of medical uses of fasting and FMD. V.D. Longo declares equity interest in L-Nutra Inc. M. Lambertini acted as a consultant for Roche, AstraZeneca, Lilly and Novartis, and received speaker honoraria from Sandoz, Roche, Takeda, Pfizer, Lilly and Novartis outside the submitted work.
- Study type
- Human clinical trial (single-arm, phase 1/2, n=90)
- Journal
- Cancers (Basel)
- Published
- 2021
- Authors
- Valdemarin F, et al.
- DOI
- 10.3390/cancers13164013
- PubMed ID
- 34439167
Summary
Ninety patients with solid or hematologic malignancies, at low nutritional risk and undergoing active medical treatment, received periodic 5-day Fasting Mimicking Diet (FMD) cycles in a single-arm phase 1/2 trial. Cycles were given every three weeks or once a month, with an average of 6.3 cycles per patient. Body weight, handgrip strength and body composition were monitored throughout, and growth factors, adipokines and cyto/chemokines were measured by ELISA.
The authors reported that the diet was largely safe, with only mild side effects, and that body weight and handgrip strength remained stable. They reported an increase in phase angle and fat-free mass and a decrease in fat mass. They reported reductions in serum c-peptide, IGF1, IGFBP3 and leptin and an increase in IGFBP1, and said these changes persisted for weeks beyond the diet period. Their conclusion is that periodic cycles are feasible and can be safely combined with standard antineoplastic treatment in patients at low nutritional risk.
This trial had a single arm and no control group, so the changes reported cannot be separated from the effects of the cancer treatment the patients were receiving at the same time. The outcomes are safety, body composition and circulating markers, not tumour or survival outcomes. Participants were cancer patients selected for being at low nutritional risk, a narrow group and not a general wellness population, and the study does not evaluate Prolon directly.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
