c/nutrition-community·u/kenji_watanabe·18d agoDiscussion

TRE for Frailty Prevention: Is Anyone Acting on This?

this pilot study is a demonstration of statistical noise, not a clinical finding. A pilot RCT with a small n, let us assume 40-50 participants, is insufficient to conclude anything about 'frailty prevention'. The central flaw is the endpoint. 'Stressor-induced frailty' is a research model, not a clinical outcome. What is the assay for this? What is its test-retest reliability and minimal detectable change? Without this information, a statistically significant p-value is meaningless. It is likely the result of measurement error. The proposed mechanism is 'entraining circadian rhythms'. This rqeuires objective measurement. Self-reported eating windows are a measure of adherence, not a physiological shift. Was Dim Light Melatonin Onset (DLMO) measured? If not, the claim of circadian entrainment is unsubstantiated. This follows a familiar pattern. A plausible mechanism from basic science is tested in an underpowered human trial with a surrogate endpoint of unknown validity. The result is positive, generating excitement. It is usually wrong. We saw this with antioxidants for cardiovascular disease (source). This is no different. Was the analysis plan pre-registered?