Vartanian Meghedi, Endres Konrad Jakob, Lee Yee Teng, Friedrich Silke, Meemken Marie-Theres, Schamarek Imke, Rohde-Zimmermann Kerstin, Schürfeld Robin, Eisenberg Lina, Hilbert Anja, Beyer Frauke, Stumvoll Michael, Sacher Julia, Villringer Arno, Christensen Julia F, Witte A Veronica
Clinic for Cognitive Neurology, University of Leipzig Medical Center, Leipzig, Germany.
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.
BMC Nutr. 2025 Jan 13;11(1):8. doi: 10.1186/s40795-024-00971-6.
Obesity is a multifactorial disease reaching pandemic proportions with increasing healthcare costs, advocating the development of better prevention and treatment strategies. Previous research indicates that the gut microbiome plays an important role in metabolic, hormonal, and neuronal cross-talk underlying eating behavior. We therefore aim to examine the effects of prebiotic and neurocognitive behavioral interventions on food decision-making and to assay the underlying mechanisms in a Randomized Controlled Trial (RCT).
This study uses a parallel arm RCT design with a 26-week intervention period. We plan to enroll 90 participants (male/diverse/female) living with overweight or obesity, defined as either a Waist-to-Hip Ratio (WHR) ≥ 0.9 (male)/0.85 (diverse, female) or a Body Mass Index (BMI) ≥ 25 kg/m. Key inclusion criteria are 18-60 years of age and exclusion criteria are type 2 diabetes, psychiatric disease, and Magnetic Resonance Imaging (MRI) contraindications. The interventions comprise either a daily supplementary intake of 30 g soluble fiber (inulin), or weekly neurocognitive behavioral group sessions, compared to placebo (equicaloric maltodextrin). At baseline and follow-up, food decision-making is assessed utilizing task-based MRI. Secondary outcome measures include structural MRI, eating habits, lifestyle factors, personality traits, and mood. Further, we obtain fecal and blood samples to investigate gut microbiome composition and related metabolites.
This study relies on expanding research suggesting that dietary prebiotics could improve gut microbiome composition, leading to beneficial effects on gut-brain signaling and higher-order cognitive functions. In parallel, neurocognitive behavioral interventions have been proposed to improve unhealthy eating habits and metabolic status. However, causal evidence on how these "bottom-up" and "top-down" processes affect food decision-making and neuronal correlates in humans is still scarce. In addition, microbiome, and gut-brain-axis-related mediating mechanisms remain unclear. The present study proposes a comprehensive approach to assess the effects of these gut-brain-related processes influencing food decision-making in overweight and obesity.
ClinicalTrials.gov NCT05353504. Retrospectively registered on 29 April 2022.
肥胖是一种多因素疾病，已达到流行程度，且医疗成本不断增加，这促使人们开发更好的预防和治疗策略。先前的研究表明，肠道微生物群在饮食行为背后的代谢、激素和神经相互作用中起着重要作用。因此，我们旨在通过一项随机对照试验（RCT）来研究益生元和神经认知行为干预对食物决策的影响，并分析其潜在机制。
本研究采用平行组RCT设计，干预期为26周。我们计划招募90名超重或肥胖的参与者（男性/多种性别/女性），超重或肥胖定义为腰臀比（WHR）≥0.9（男性）/0.85（多种性别、女性）或体重指数（BMI）≥25kg/m²。主要纳入标准为年龄在18至60岁之间，排除标准为2型糖尿病、精神疾病和磁共振成像（MRI）禁忌症。干预措施包括每天补充30克可溶性纤维（菊粉），或每周进行神经认知行为小组会议，与安慰剂（等热量麦芽糖糊精）进行比较。在基线和随访时，利用基于任务的MRI评估食物决策。次要结局指标包括结构MRI、饮食习惯、生活方式因素、人格特质和情绪。此外，我们采集粪便和血液样本以研究肠道微生物群组成和相关代谢物。
本研究依赖于不断扩展的研究，表明膳食益生元可以改善肠道微生物群组成，对肠脑信号和高级认知功能产生有益影响。同时，有人提出神经认知行为干预可以改善不健康的饮食习惯和代谢状态。然而，关于这些“自下而上”和“自上而下”过程如何影响人类食物决策和神经元相关性的因果证据仍然很少。此外，微生物群和肠脑轴相关的中介机制仍不清楚。本研究提出了一种综合方法来评估这些与肠脑相关的过程对超重和肥胖人群食物决策的影响。
ClinicalTrials.gov NCT05353504。于2022年4月29日进行回顾性注册。
