Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Significant change in cerebral activity in zones involved in food intake inhibition control
研究概览
简要总结
This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires.
The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation Unit.
During this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home.
The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.
Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on the Neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-24,
- •Presenting a normal BMI (18-25),
- •Right-handers,
- •Affiliated to a social security scheme
- •Having given a free, informed and written consent.
- •Having a low frequency of consumption of fatty and / or sugary / salty foods, or on the contrary, a high frequency of consumption of these foods.
排除标准
- •Related to the study:
- •High level athletes, (determined on the basis of the Ricci & Gagnon questionnaire - excluded if score > 32);
- •Food abstinents for religious, ideological or health reasons (intolerance, vegetarianism, allergies, etc.);
- •Family history of obesity or diabetes;
- •Personal history of TCA, anxiety or depressive disorder, or proven addictive behaviour;
- •Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the AUDIT questionnaires - excluded if score > 7 and CRAFT - excluded if score> 2 " yes ");
- •Smoking daily or having stopped for less than 6 months;
- •History of bariatric surgery;
- •On-going treatment in the nutrition unit;
- •Insufficient command of French;
- •Pregnant or nursing women;
- •Persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
- •Simultaneous participation in another research protocol involving the human person
- •Related to fMRI:
- •Implantable cardiac pacemaker or defibrillator;
- •Neurosurgical clips;
- •Cochlear implants;
- •Neural or peripheral stimulator;
- •Foreign orbital or brain metallic foreign bodies;
- •Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
- •Claustrophobia.
研究组 & 干预措施
high consumption habits
high consumption habits of fatty and sugary foods
干预措施: First Visit (Other)
high consumption habits
high consumption habits of fatty and sugary foods
干预措施: on-line questionnaires (Other)
high consumption habits
high consumption habits of fatty and sugary foods
干预措施: fMRI (Device)
low consumption habits
low consumption habits of fatty and sugary foods
干预措施: First Visit (Other)
low consumption habits
low consumption habits of fatty and sugary foods
干预措施: on-line questionnaires (Other)
low consumption habits
low consumption habits of fatty and sugary foods
干预措施: fMRI (Device)
结局指标
主要结局
Significant change in cerebral activity in zones involved in food intake inhibition control
时间窗: at 2 weeks
Significant change in cerebral activity (expressed as a significant variation in hemodynamic response BOLD in the condition of food cognitive tasks) in zones involved in food intake inhibition control (dorso-lateral prefrontal cortex, upper frontal gyrus)
次要结局
- Significant change in cerebral activity in areas involved in the control of reward and motivation (striatum dorsal, insula), associated with modulation of the intestinal microbiota and metabolic and hormonal homeostasis.(at 2 weeks)