Fructose Effect on Neuroinflammation and Feelings: Direct Action on the Brain or Indirect by the Intestinal Microbiota?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
研究概览
简要总结
Fructose is increasingly present in our food. The increase in its consumption is associated with the increase in the prevalence of several pathologies such as metabolic syndrome or hepatic steatosis. The effect of fructose consumption on brain health has been poorly studied. Studies in animal models show that diets enriched in fructose promote the development of emotional behavior disorders. Fructose malabsorption is also associated with changes in the microbiota that could also impact brain health. However, no human study to date has associated fructose malabsorption with changes in the gut microbiota and effects on brain health.
The objective of this study is to study the emotional behavior of a population of healthy volunteers according to the presence or not of fructose malabsorption. Patients with fructose malabsorption are susceptible to gut dysbiosis without necessarily consuming high amounts of fructose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Aged 18 to 35
- •BMI between 18.5 and 25
- •Affiliation to a social security scheme
- •Adult patient having read and understood the information letter and signed the consent form
排除标准
- •Presence of irritable bowel syndrome, celiac disease
- •Presence of a psychiatric illness
- •Presence of a neurodegenerative disease
- •Presence of an eating disorder
- •Presence of chronic disease, including inflammatory disease
- •Presence of diabetes
- •Presence of an acute infectious disease
- •Presence of a surgical history of the digestive tract (excluding appendectomy)
- •Taking long-term treatment
- •Taking antibiotics within 6 months
- •Taking probiotics within 3 months
- •Typical diet low in lactose, FODMAP, gluten, vegetarian, vegan, vegan, chromonutrition .... in progress
- •Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship
- •Simultaneous participation in another interventional clinical trial
研究组 & 干预措施
Healthy volunteers
干预措施: Fructose respiratory test (Other)
结局指标
主要结局
Evaluate the chronic effect of fructose on anxiety in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.
时间窗: Day 1
Spielberger State Anxiety Questionnaire Score (STAI) with 20 items rated from 1(none) to 4 (a lot).
次要结局
- Evaluate the chronic effect of fructose on microbiota's composition in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.(up to 1 month)
- Evaluate the chronic effect of fructose on low-grade intestinal inflammation in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.(up to 1 month)
- Evaluate the fructose consumption in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.(For 7 days before day 30)
- Evaluate the chronic effect of fructose on depression in healthy volunteers with fructose malabsorption compared to healthy volunteers without fructose malabsorption.(Day 1)