Time-Restricted Eating in Huntington's Disease: A Clinical Pilot Study (TREHD)
Description
This trial examines whether 12 weeks of time-restricted eating (TRE), otherwise known as intermittent fasting, appears safe and feasible in persons with early-stage Huntington's disease (HD). The study also explores the effects of TRE on biomarkers and clinical measures associated with HD progression. ClinicalTrials.gov ID: NCT06490367
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Steps to reproduce
Protocol: https://doi.org/10.1371/journal.pone.0319253 Statistics: Statistical analyses were performed using STATA statistical software, version 18.0 (College Station, TX: StataCorp LLC) and GraphPad Prism, version 10.2 (San Diego, CA). For all outcomes comparing two continuous variables, normality of the change score was first assessed using the Shapiro-Wilk Test. If change scores exhibited normal distribution, then a paired-samples t-test was employed. If the change score did not display normality (p<0.05), then a non-parametric Wilcoxon-signed rank test was applied. The Wilcoxon-signed rank test was also used to compare changes in discrete ordinal variables on scales ≤ 10 (i.e., quality of life, pain, fatigue, and psychiatric outcomes). For outcomes collected at more than two timepoints, descriptive statistics were supplemented with visual representations of longitudinal data, such as line plots, to illustrate trends and inter/intra-individual variability. Pearson’s partial correlation coefficients adjusted for age were calculated to explore associations between variables and study endpoints. All analyses were performed in the per protocol population (i.e., 20 participants who completed the 1-week lead-in and 12 weeks of TRE). Baseline and follow-up data are presented as mean ± standard deviation (SD) and/or median [Interquartile Range (IQR)]. Statistical level of significance was set at P value < 0.05, two-sided. Due to the exploratory nature of this study, reported P values were not adjusted for multiple comparisons.
Institutions
- Oregon Health & Science UniversityOR, Portland