跳至主要内容
临床试验/NCT07557628
NCT07557628招募中不适用

Study of the Hypothalamic Microglial Response as a Function of a Meal's Lipid Content in Humans. A Single-center Prospective Cohort Study in Healthy Male Subjects

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
The difference in hypothalamic MRI signal intensity between the baseline state and the postprandial state observed after a balanced meal and after a high-fat meal for each subject.

研究概览

简要总结

Obesity and its complications represent a growing public health problem in our society. A better understanding of the biological mechanisms involved in regulating food intake-and, more broadly, energy metabolism-should lead to improved management of this condition.

Recent studies have shown that eating a single meal can rapidly trigger the activation of the immune system. This leads to a postprandial, systemic, and transient inflammatory response (Emerson SR, Adv Nutr 2017). It is found in both healthy and obese individuals. It has also been observed in rodents, enabling preclinical studies to better understand the phenomenon. This postprandial inflammation is characterized by the activation of macrophages in the gastrointestinal tract and by elevated levels of circulating pro-inflammatory markers. At the cellular level, nutrients activate an intracellular molecular sensor called the inflammasome, which is a multiprotein complex formed by the oligomerization of proteins including NLRP3 (Nod-like receptors pyrin domain-containing 3) and ASC (Apoptosis-associated Speck-like protein containing a CARD domain). This sensor activates caspase 1, an enzyme that converts pro-interleukin 1β (pro-IL-1β) into its mature and active form, IL-1β. This molecular mechanism converts the nutritional signal into an immune response.

Under physiological conditions, this acute response appears to have beneficial effects on the body. Indeed, it plays a positive role in blood glucose control by stimulating insulin secretion and glucose utilization (Dror, Nat Immunol 2017). However, in the context of chronic overeating and excessive consumption of saturated fats and simple sugars, this systemic inflammation becomes harmful, promoting adipocyte hypertrophy, insulin resistance, hepatic steatosis, and vascular damage (Hotamisligil, Nature 2017).

In mice, our team recently demonstrated the existence of a postprandial inflammatory response in the central nervous system (Cansell, Glia 2021). This response occurs specifically in the hypothalamus, a brain structure involved in regulating food intake and controlling energy metabolism. It is characterized by microglial reactivity visible as early as 3 hours after the start of the postprandial phase. This postprandial microglial activation occurs after the ingestion of a high-fat meal, whereas it is rarely or never observed after the ingestion of a standard balanced meal. It is characterized by a morphological change in hypothalamic microglia, including an increase in the length of microglial processes and their branching. This gliosis is associated with increased expression of IL-1β in microglial cells. Thus, the postprandial gliosis observed 3 hours after a high-fat meal is inflammatory. Using a targeted genetic approach that allows for the ablation of the inflammasome in microglial cells, the team demonstrates that postprandial gliosis exerts a satiating effect, limiting subsequent food intake following a high-calorie, high-fat meal. Thus, microglial inflammation appears to be an additional component in the body's arsenal of adaptive homeostatic responses aimed at limiting energy intake.

Our clinical project will involve translating our basic findings in mice to humans. This will involve investigating postprandial hypothalamic gliosis in the human brain following a standard meal or a high-fat meal. The initial studies will be conducted exclusively in healthy male subjects to avoid the influence of the hormonal cycle on the hypothalamic response. The impact of physiological aging on the hypothalamic microglial inflammatory response will also be taken into account.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • A person who has given oral consent
  • Male
  • Body Mass Index (BMI) between 18.5 and 30 kg/m²
  • Age ≥ 20 years

排除标准

  • A person subject to a measure of legal protection (guardianship, tutorship)
  • A person subject to a judicial protective measure
  • A person who is not enrolled in or eligible for a social security program
  • Subject does not speak French
  • Subjects with a pacemaker or any other contraindication to MRI
  • Subjects with type 1 or type 2 diabetes
  • Subjects with a chronic inflammatory condition
  • Subjects with a neuropsychiatric condition
  • Subjects taking anti-inflammatory medication or medication that affects the central nervous system
  • Known hypersensitivity to foods provided during the study

研究组 & 干预措施

Male subjects

Healthy volunteers to study the biological mechanisms that control food intake and energy metabolism

干预措施: Blood sample (Biological)

Male subjects

Healthy volunteers to study the biological mechanisms that control food intake and energy metabolism

干预措施: Brain MRI without contrast, performed on an empty stomach and after a meal (Procedure)

Male subjects

Healthy volunteers to study the biological mechanisms that control food intake and energy metabolism

干预措施: Questionnaires (Other)

Male subjects

Healthy volunteers to study the biological mechanisms that control food intake and energy metabolism

干预措施: Bioelectrical impedance analysis (Other)

结局指标

主要结局

The difference in hypothalamic MRI signal intensity between the baseline state and the postprandial state observed after a balanced meal and after a high-fat meal for each subject.

时间窗: 2 days

Measurement of hypothalamic T2 relaxation time

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

Loading locations...

标识符

NCT 编号
NCT07557628
其他研究编号
SCHNEIDER 2025

日期

首次提交
(5个月前)
首次发布
(5个月前)
主要完成日期
(明年)
研究完成日期
(明年)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
是否有结果
否

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