Effects of Citrus depressa Hayata Fruit Extract on Thigh Muscles Mass and Composition in Subacute Stroke Patients: A Double-Blind, Randomized, Controlled Pilot Trial

OBJECTIVE: This pilot study evaluated the effects of Citrus depressa Hayata fruit extract (CFEx) on thigh muscle cross-sectional area (CSA) and composition in subacute stroke patients with hemiparesis who were undergoing rehabilitation. DESIGN AND INTERVENTION: This double-blinded, placebo-controlled, randomized pilot trial included 40 subacute stroke patients with moderate-to-severe hemiparesis, and they were randomly assigned to receive CFEx or placebo supplements for 12 weeks. The thigh muscle CSA was measured by computed tomography as total muscle area defined by Hounsfield units (HU) values of −29 to 150 HU. The total muscle area was divided into muscle area with fat infiltration and normal muscle area to evaluate muscle composition (−29 to 29 and 30 to 150 HU, respectively). RESULTS: At baseline, the total muscle area and normal muscle area in the paretic thigh were lower than those in the nonparetic thigh. The nonparetic normal muscle area was significantly higher in the CFEx group than in the placebo group at 12 weeks, whereas the total muscle area was not different. CONCLUSIONS: The thigh muscle CSA and composition in the paretic side have already deteriorated in patients with moderate-to-severe hemiparesis at the subacute stroke stage. CFEx supplementation during rehabilitation might improve the nonparetic thigh muscle composition in subacute stroke patients. Findings of this study are needed to be verified by a large-scale randomized trial since this study was a pilot study with a small sample size. Trial registration: UMIN Clinical Trial Registry (UMIN ID: UMIN000012902).