PDF(Pubmed)
Abstract：
Taste disorders (TDs) are common among systemically treated cancer patients and negatively impact their nutritional status and quality of life. The novel food approved by the European Commission (EFSA), dried miracle berries (DMB), contains the natural taste-modifying protein miraculin. DMB, also available as a supplement, has emerged as a possible alternative treatment for TDs. The present study aimed to evaluate the efficacy and safety of habitual DMB consumption in malnourished cancer patients undergoing active treatment. An exploratory clinical trial was carried out in which 31 cancer patients were randomized into three arms [standard dose of DMB (150 mg DMB/tablet), high dose of DMB (300 mg DMB/tablet) or placebo (300 mg freeze-dried strawberry)] for three months. Patients consumed a DMB tablet or placebo daily before each main meal (breakfast, lunch, and dinner). Throughout the five main visits, electrochemical taste perception, nutritional status, dietary intake, quality of life and the fatty acid profile of erythrocytes were evaluated. Patients consuming a standard dose of DMB exhibited improved taste acuity over time (% change right/left side: -52.8 ± 38.5/-58.7 ± 69.2%) and salty taste perception (2.29 ± 1.25 vs. high dose: 2.17 ± 1.84 vs. placebo: 1.57 ± 1.51 points, p < 0.05). They also had higher energy intake (p = 0.075) and covered better energy expenditure (107 ± 19%). The quality of life evaluated by symptom scales improved in patients receiving the standard dose of DMB (constipation, p = 0.048). The levels of arachidonic (13.1 ± 1.8; 14.0 ± 2.8, 12.0 ± 2.0%; p = 0.004) and docosahexaenoic (4.4 ± 1.7; 4.1 ± 1.0; 3.9 ± 1.6%; p = 0.014) acids in erythrocytes increased over time after DMB intake. The standard dose of DMB increased fat-free mass vs. placebo (47.4 ± 9.3 vs. 44.1 ± 4.7 kg, p = 0.007). Importantly, habitual patients with DMB did not experience any adverse events, and metabolic parameters remained stable and within normal ranges. In conclusion, habitual consumption of a standard 150 mg dose of DMB improves electrochemical food perception, nutritional status (energy intake, fat quantity and quality, fat-free mass), and quality of life in malnourished cancer patients receiving antineoplastic treatment. Additionally, DMB consumption appears to be safe, with no changes in major biochemical parameters associated with health status. Clinical trial registered (NCT05486260).
摘要：
味觉障碍（TD）在全身治疗的癌症患者中很常见，会对他们的营养状况和生活质量产生负面影响。欧盟委员会（EFSA）批准的新型食品，干奇迹浆果（DMB），含有天然的调味蛋白miraculin。DMB,也可以作为补充，已经成为TDs的一种可能的替代疗法。本研究旨在评估习惯性DMB消耗在接受积极治疗的营养不良癌症患者中的疗效和安全性。进行了一项探索性临床试验，其中31名癌症患者被随机分为三组[标准剂量的DMB（150mgDMB/片），高剂量的DMB（300mgDMB/片）或安慰剂（300mg冻干草莓）]三个月。患者在每次主餐前每天服用DMB片剂或安慰剂(早餐，午餐,和晚餐）。在五次主要访问中，电化学味觉感知，营养状况,饮食摄入量，评价了生活质量和红细胞脂肪酸谱.服用标准剂量DMB的患者随着时间的推移表现出改善的味觉敏锐度（右/左侧变化百分比：-52.8±38.5/-58.7±69.2％）和咸味感（2.29±1.25vs.高剂量：2.17±1.84vs.安慰剂：1.57±1.51分，p<0.05)。他们还具有更高的能量摄入（p=0.075），并涵盖了更好的能量消耗（107±19％）。接受标准剂量DMB（便秘，p=0.048)。摄入DMB后，随着时间的推移，红细胞中花生四烯酸（13.1±1.8；14.0±2.8，12.0±2.0％；p=0.004）和二十二碳六烯酸（4.4±1.7；4.1±1.0；3.9±1.6％；p=0.014）的水平增加。DMB的标准剂量增加了无脂肪质量与安慰剂(47.4±9.3vs.44.1±4.7kg,p=0.007)。重要的是,患有DMB的习惯性患者没有经历任何不良事件，和代谢参数保持稳定并在正常范围内。总之,习惯食用标准的150毫克剂量的DMB改善电化学食物感知，营养状况(能量摄入，脂肪的数量和质量，无脂肪质量)，接受抗肿瘤治疗的营养不良癌症患者的生活质量。此外,DMB消耗似乎是安全的，与健康状况相关的主要生化参数没有变化。临床试验注册(NCT05486260)。
