METHODS: We conducted a single-site randomized controlled trial (Clinicaltrials.gov NCT05143398) with 40 in-patient male subjects with severe obesity. Participants underwent an intervention program consisting of a low-calorie balanced diet and structured physical activity. They were randomly assigned to 4-week treatment groups: (1) control (CTR, N = 10), (2) protein (P, N = 10), (3) branched-chain amino acid (BCAA, N = 10), and (4) essential amino acid mixture with tricarboxylic acid cycle intermediates (PD-E07, N = 10) supplementation.
RESULTS: Following 4 weeks of intervention, all groups showed similar reductions in body weight compared to baseline. When examining the delta values, a notable increase in muscle mass (MM) was observed in the PD-E07 intervention group [MM (kg): 2.84 ± 3.57; MM (%): 3.63 ± 3.14], in contrast to the CTR group [MM (kg): -2.46 ± 3.04; MM (%): -0.47 ± 2.28], with a statistical significance of p = 0.045 and p = 0.023, respectively. However, the MM values for the P group [MM (kg): -2.75 ± 5.98, p = 0.734; MM (%): -0.44 ± 4.02, p = 0.990] and the BCAA group [MM (kg): -1 ± 3.3, p = 0.734; MM (%): 0.34 ± 2.85, p = 0.956] did not exhibit a statistically significant difference when compared to the CTR group.
CONCLUSIONS: Amino acid-based supplements may effectively mitigate the loss of MM typically observed during weight reduction. Further validation through large-scale studies is necessary.
方法:我们进行了一项单中心随机对照试验(Clinicaltrials.govNCT05143398),纳入了40名重度肥胖住院男性受试者。参与者接受了一项干预计划,包括低热量均衡饮食和结构化身体活动。他们被随机分配到4周治疗组:(1)对照组(CTR,N=10),(2)蛋白质(P,N=10),(3)支链氨基酸(BCAA,N=10),和(4)补充有三羧酸循环中间体(PD-E07,N=10)的必需氨基酸混合物。
结果:干预4周后,与基线相比,所有组的体重减轻相似.检查delta值时,在PD-E07干预组中观察到肌肉质量(MM)显着增加[MM(kg):2.84±3.57;MM(%):3.63±3.14],对比CTR组[MM(kg):-2.46±3.04;MM(%):-0.47±2.28],统计学意义分别为p=0.045和p=0.023。然而,P组的MM值[MM(kg):-2.75±5.98,p=0.734;MM(%):-0.44±4.02,p=0.990]和BCAA组[MM(kg):-1±3.3,p=0.734;MM(%):0.34±2.85,p=0.956]与CTR组相比,差异无统计学意义。
结论:基于氨基酸的补充剂可以有效减轻体重减轻过程中常见的MM损失。通过大规模研究进一步验证是必要的。