特定氨基酸混合物治疗住院神经性厌食症患者的疗效和耐受性：一项随机对照试验的研究方案。

Efficacy and tolerability of a specific blend of amino acids in patients with anorexia nervosa treated in a hospital setting: study protocol for a randomized controlled trial.

机构信息

Department of Eating and Weight Disorders, Villa Garda Hospital, Via Monte Baldo, 89, Garda, 37016, Verona, Italy.

Center for Study and Research on Obesity, Department of Biomedical Technology and Translational Medicine, University of Milan, Via Vanvitelli, 32, 20129, Milan, Italy.

出版信息

Trials. 2023 Feb 9;24(1):104. doi: 10.1186/s13063-023-07120-7.

DOI:10.1186/s13063-023-07120-7

PMID:36759873

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9912576/

Abstract

BACKGROUND

Specific blends of essential amino acids (EAA) containing a high percentage of branched-chain amino acids preserves mitochondrial metabolism and higher physical resistance in elderly mice, increasing their survival and improving physical performance and cognitive functions in malnourished elderly patients. However, no study has been yet done on patients with anorexia nervosa (AN) who regain weight with specialized intensive treatment. The present study aims to evaluate the efficacy of supplementation with EAA on the change in lean body mass (LBM) and other physical and psychological outcomes in patients with AN who are undergoing specialist treatment for eating disorders.

METHODS

This is a 13-week randomized, double-blind, placebo-controlled study. Patients will be randomized to either a mixture of a complex blend of EAA and intermediates of the tricarboxylic acid (TCA) cycle (citrate, malate, succinate) supplementation (or placebo) upon admission at the intensive residential and day-hospital treatment for eating disorders. Ninety-two participants with AN aged 16-50 years will be recruited from a specialized intensive treatment of eating disorders. Double-blind assessment will be conducted at baseline (T0) and the end of the 13 weeks of treatment (T1). The study's primary aim is to evaluate the efficacy of supplementation with EAA and TCA intermediates on the change in lean body mass (LBM) with weight restoration in patients with AN who are undergoing specialist treatment for eating disorders. The secondary aims of the study are to assess the effect of dietary supplementation on physical fitness, weight restoration, modification of AN and general psychopathology, and psychosocial impairment.

DISCUSSION

The study's results will inform researchers and clinicians on whether supplementing a mixture of EAA and TCA cycle intermediates will improve the increase of LBM and other important physical and psychological outcomes in patients with AN who regain weight with specialized intensive treatment.

TRIAL REGISTRATION

NCT, NCT05290285. Registered on 22 March 2022.

摘要

背景

特定比例的必需氨基酸（EAA）混合物，其中含有高比例的支链氨基酸，可维持线粒体代谢和提高老年小鼠的身体抵抗力，增加其生存时间，并改善营养不良的老年患者的身体机能和认知功能。然而，目前尚未对接受专门强化治疗以恢复体重的神经性厌食症（AN）患者进行相关研究。本研究旨在评估补充 EAA 对接受饮食障碍专科强化治疗的 AN 患者的瘦体重（LBM）变化及其他身体和心理结果的疗效。

方法

这是一项为期 13 周的随机、双盲、安慰剂对照研究。患者将在接受饮食障碍强化住院和日间医院治疗时，随机分为接受 EAA 混合物和三羧酸（TCA）循环中间体（柠檬酸盐、苹果酸盐、琥珀酸盐）补充剂（或安慰剂）治疗。将从专门的饮食障碍强化治疗中招募 92 名年龄在 16-50 岁之间的 AN 患者。在基线（T0）和 13 周治疗结束时（T1）进行双盲评估。该研究的主要目的是评估补充 EAA 和 TCA 中间体对接受饮食障碍专科强化治疗以恢复体重的 AN 患者的 LBM 变化及体重恢复的疗效。研究的次要目的是评估饮食补充对身体适应性、体重恢复、AN 及一般精神病理学和心理社会障碍的影响。