Efficacy and Tolerability of a Specific Blend of Amino Acids in Patients With Anorexia Nervosa Treated in a Hospital Setting. Double-blind Randomized Study Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Lean body mass
研究概览
简要总结
Amino acids (AAs) are crucial for protein synthesis, in influencing nutritional status, as sources of vital elements (e.g., nucleotides, neurotransmitters) and as signal molecules for the modulation of gene expression and epigenetic mechanisms. Data on the role of amino acids in underweight patients with anorexia nervosa (AN) are unknown. This study aims to evaluate whether a blend of essential amino acids (EAA) could influence the change in lean body mass (LBM) in patients with AN during weight restoration, treated with intensive inpatient enhanced cognitive behavior therapy (CBT-E). A total of 92 patients will be randomized to EAA supplementation or placebo supplementation upon admission to inpatient treatment. LBM, but also body weight, specific and general psychopathology, impairment assessment will be assessed at baseline and after 13 weeks of treatment.
详细描述
Nutrition is one of the main determinants of health. Among the three primary macronutrients, proteins - specifically, their quantity and quality (i.e., their specific amino acid profile) - play a crucial role in regulating metabolic health and longevity. Amino acids (AAs) are crucial not only for protein synthesis and influencing nutritional status but also as sources of vital elements (e.g., nucleotides, neurotransmitters) and as signal molecules for the modulation of gene expression and epigenetic mechanisms. To our knowledge, only one study was conducted on underweight patients with anorexia nervosa (AN). The study design was to compare the efficacy of the semi-essential amino acid L-tyrosine (100 mg/kg/day) versus a placebo supplement. Tyrosine reduced reaction time and test duration in memory tasks and improved mood. However, to date, no studies have evaluated the effect of supplementation with amino acids in patients with anorexia nervosa who undergo specialist treatment aimed at weight recovery and remission from psychopathology.
The study has the primary aim of evaluating the effectiveness of supplementation with essential amino acids (EAA) on the change in lean body mass (LBM) with weight recovery in patients with AN treated with specialist treatment for eating disorders, compared to placebo supplementation. The secondary aims of the study are to evaluate the effectiveness of EAA supplementation on physical fitness, weight recovery, change of the general and eating disorder psychopathology, and psychosocial impairment, compared to placebo supplementation.
A 13-week randomized double-blind placebo-controlled study design will be used.
Patients will be randomized to EAA supplementation or placebo supplementation upon admission. Randomization will be carried out by an independent external figure adopting the following stratification:
Group 1: Body Mass Index (BMI) <= 15.2 & age <= 20 Group 2: BMI > 15.2 & age <= 20 Group 3: BMI <= 15.2 & age > 20 Group 4: BMI > 15.2 & age > 20 Treatment will involve a 13-week inpatient or a 13-week day hospital. Follow-up will be performed for both groups at 24 weeks. Considering that it will not be possible to carry out a closed follow-up, we will give the possibility to those who have taken the mixture of EAA to continue this treatment after the end of inpatient or day-hospital, for other 24 weeks, to evaluate the potential long-term maintenance of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind RCT
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of anorexia nervosa
- •Age between 16 and 50 years
- •Written informed consent
排除标准
- •Schizophrenia or other psychotic disorders
- •Diagnosis of bulimia nervosa
- •Current and ongoing substance use disorder
- •Medical complications capable of hindering the interpretation of the results (e.g. a a medical disease that induces weight loss)
- •Presence of physical treatments (including drugs) hindering the interpretation of the results (e.g. chemotherapy for cancer)
- •Being pregnant or intending to become pregnant during treatment
研究组 & 干预措施
EAA supplementation
The EAA blend consists of a complex blend of essential amino acids, including some precursors of neurotransmitters that are important for regulating mood. In particular, phenylalanine, a precursor of tyrosine (non-essential amino acid) is involved in the biosynthesis of catecholamines (noradrenaline, adrenaline, dopamine) and tryptophan is the precursor of serotonin. Furthermore, the amino acids present in the mixture and the precursors of the Krebs cycle (citrate, malate, succinate) are able to stimulate mitochondrial bioenergetics by improving metabolism and muscle function.
The EAA blend will be administered orally at 4.5 g twice daily (two sachets of Amino-Ther Pro per day).
干预措施: Amino-Ther Pro (Dietary Supplement)
Placebo
Placebo is an isocaloric product containing maltodextrins instead of amino acids (Acquilani et al., 2011). The placebo will be administered orally 4.5 g twice daily.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Lean body mass
时间窗: From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)
Percentage change in patient's lean body mass with weight gain at the end of hospital treatment, measured using the DXA (Prodigy Primo Lunar, A223040501, General Electric Company, Madison. WI 53707-7550, USA-EnCORE TM 2009 (v13.31) software)
次要结局
- General psychopathology(From baseline (admission to inpatient) to end of hospitalization (after 13 weeks))
- Clinical impairment(From baseline (admission to inpatient) to end of hospitalization (after 13 weeks))
- Physical fitness(From baseline (admission to inpatient) to end of hospitalization (after 13 weeks))
- Body weight(From baseline (admission to inpatient) to end of hospitalization (after 13 weeks))
- Eating disorder psychopathology(From baseline (admission to inpatient) to end of hospitalization (after 13 weeks))
研究者
Riccardo Dalle Grave
M.D.
Villa Garda Hospital