Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment.
Level 4 - case-series / case-control
Single-arm, uncontrolled phase I/II clinical trial
PubMed 34439167 · doi:10.3390/cancers13164013
What was done
In a single-arm, phase I/II trial (NCT03595540), 90 patients with solid or hematologic malignancies at low nutritional risk receiving active medical treatment underwent periodic 5-day Fasting-Mimicking Diet (FMD) cycles every 3 weeks or once monthly (average 6.3 cycles/patient). Safety, feasibility, body weight, handgrip strength, body composition, and circulating biomarkers (growth factors, adipokines, and cyto/chemokines via ELISA) were assessed.
What was found
FMD was reported as safe with only mild side effects. Body weight and handgrip strength remained stable, while fat-free mass and phase angle increased, and fat mass decreased. FMD decreased serum C-peptide, IGF1, IGFBP3, and leptin, while increasing IGFBP1, with changes persisting for weeks. The abstract reports no numerical values, effect sizes, or confidence intervals.
Why it matters
The study suggests that fasting-mimicking diets can be safely administered alongside active antineoplastic treatments without causing muscle wasting in patients at low baseline nutritional risk.
Limits
The study lacked a randomized control group, preventing causal attribution of changes to the diet versus concurrent treatments or natural course. It excluded patients with elevated nutritional risk or cachexia, limiting generalizability. No numerical data, exact compliance rates, or clinical oncologic outcomes (such as response rate or survival) were reported in the abstract.