Czernichow Sébastien, Rassy Nathalie, Carette Claire, Shoung Nicholas, Hu Frank B, Rives-Lange Claire
Assistance Publique-Hôpitaux de Paris (AP-HP), Service de Nutrition, Centre Spécialisé Obésité, Hôpital Européen Georges Pompidou, Paris, France.
Université Paris Cité, Paris, France.
Obes Rev. 2025 May;26(5):e13890. doi: 10.1111/obr.13890. Epub 2025 Jan 27.
Currently, trials are investigating the efficacy of nutrient-stimulated hormone-based therapies (NuSHs) in promoting weight loss in people living with overweight and obesity. However, the extent to which nutritional and functional outcomes are evaluated remains uncertain. Thus, we conducted a systematic mapping to assess the presence of nutritional and functional outcomes in randomized controlled trials (RCTs) investigating NuSHs.
We conducted a systematic mapping search on the Cochrane Central Register of Controlled Trials (CENTRAL), which includes ClinicalTrials.gov and the International Clinical Trials Registry Platform for interventional trials of NuSHs registered from inception to December 31, 2023. We excluded non- and quasi-randomized trials, phase I trials, trials that did not include body weight as a primary or secondary outcome, trials with an intervention duration of less than 6 months, and trials that did not specify a body mass index threshold in their eligibility criteria. Outcomes included: dietary intake, eating behavior, body composition, physical performance, muscle strength, bone health, and levels of vitamins, trace elements, albumin, prealbumin, and hemoglobin.
The search identified 2284 trials, of which 417 were included in the analysis. The proportion of RCTs that included nutritional assessment other than body weight increased over time. Approximately, 20.4% reported measurements of body composition, 17.3% reported measurements of albumin/prealbumin/hemoglobin, and 17% reported assessment of dietary intake and eating behavior. Evaluations of bone health, physical performance, muscle strength, and measurements of vitamins/trace elements were reported in less than 5% of the total trials each.
The present review has shown the sparse reporting of nutritional and functional outcomes in RCTs evaluating the impact of NuSHs.
目前，多项试验正在研究基于营养刺激激素的疗法（NuSHs）在促进超重和肥胖人群体重减轻方面的疗效。然而，营养和功能结局的评估程度仍不确定。因此，我们进行了一项系统映射研究，以评估在调查NuSHs的随机对照试验（RCTs）中营养和功能结局的存在情况。
我们在Cochrane对照试验中央登记册（CENTRAL）上进行了系统映射搜索，其中包括ClinicalTrials.gov和国际临床试验注册平台，以查找从开始到2023年12月31日注册的NuSHs干预试验。我们排除了非随机和半随机试验、I期试验、未将体重作为主要或次要结局的试验、干预持续时间少于6个月的试验，以及在纳入标准中未指定体重指数阈值的试验。结局包括：饮食摄入量、饮食行为、身体成分、身体机能、肌肉力量、骨骼健康以及维生素、微量元素、白蛋白、前白蛋白和血红蛋白水平。
搜索确定了2284项试验，其中417项纳入分析。除体重外还包括营养评估的RCT比例随时间增加。大约20.4%报告了身体成分测量，17.3%报告了白蛋白/前白蛋白/血红蛋白测量，17%报告了饮食摄入量和饮食行为评估。骨骼健康、身体机能、肌肉力量评估以及维生素/微量元素测量在所有试验中的报告比例均低于5%。
本综述表明，在评估NuSHs影响的RCT中，营养和功能结局的报告较少。
