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How Altered Gut-Brain-Axis Influences Food Choices: Part 1 (BrainFood)

2022年9月22日 更新者:Lia Bally

How Altered Gut-Brain-Axis Influences Food Choices. (BrainFood) Part 1: Brain Imaging and Computational Modelling

Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. Surgical rearrangement of the gastrointestinal tract remarkably alters metabolism and hormones acting on neurological and hypothalamic signalling involved in food decision-making and eating behaviour. In this context, many patients who underwent bariatric surgery self-report changes in appetite, satiety and food preferences. Furthermore, new gut hormone-based (e.g. GLP1-receptor agonist or GLP-1-RA) pharmacotherapies which mimic the effect of bariatric surgery show impressive efficacy on weight reduction by modulation of food behaviour. However, the mechanisms of such functional changes, and how they relate to food decision-making remain unknown.

In this project, the investigators propose a novel approach to unravel the effect of obesity treatments (surgical and non-surgical) on the neural coding of nutritional attributes and its impact on dietary choices using a combination of brain imaging, computational modelling of food behaviour and assessment of eating and food purchase behaviour in daily life.

研究概览

详细说明

The overall aim of this project is to elucidate the neurobehavioural underpinnings of food behaviour among obese adults and how food behavior is altered by different obesity treatments.To this end, the study consists of an experimental setting combining neurobehavioural tasks, computational modelling and functional brain imaging.

The main objective of Part 1 of the BrainFood-project is to elucidate if neural coding and food behaviour differ between obese adults and lean adults. The investigators hypothesize that subjective neural processes of nutritional food attributes differ between the obese and control participants, showing an unhealthier pattern among obese participants.

To this aim, the outcomes will be compared between groups (surgery group and control group).

研究类型

观察性的

注册 (实际的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bern、瑞士、3010
        • Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Pilot protocol:

5 obese adults planned for bariatric surgery (Group 1) will be recruited by referral from our outpatient endocrine clinic and collaborating Centres of Excellence for Metabolic Surgery.

5 lean healthy adults (Group 2) matched for age-, sex- and education will serve as a control group and will be recruited through advertisement according to guidelines from swissethics.

Refined protocol:

20 obese adults planned for obesity treatment (Group 1) will be recruited by referral from our outpatient endocrine clinic and collaborating Centres of Excellence for Metabolic Surgery.

20 lean healthy adults (Group 2) matched for age and sex will serve as a control group and will be recruited through advertisement according to guidelines from swissethics.

描述

Inclusion criteria (all participants):

  • Female and male subjects aged 18 years or older
  • Proficient German language skills (including written)

Inclusion criteria for Group 1 (pilot protocol):

  • Class II-III obesity (BMI≥35kg/m2)
  • Planned for bariatric surgery (Roux-en-Y gastric bypass)

Inclusion criteria for Group 1 (refined protocol):

  • BMI≥30kg/m2 or BMI≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia)
  • Referred for obesity treatment (surgical or non-surgical)

Inclusion criteria for Group 2 (pilot and refined protocols):

  • Normal body weight (BMI 18.5-24.9kg/m2)
  • Absence of evidence of any active or chronic disease as judged by the Clinical Investigator

Exclusion criteria:

  • Incapacity to give informed consent
  • Previous or current neurological or severe psychiatric illness
  • Current or planned pregnancy or breastfeeding
  • Claustrophobia
  • MRI-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)
  • Pilot protocol only: Diabetes according to WHO (World Health Organization ) definition (Fasting plasma glucose ≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Obesity group (group 1)

Pilot phase:

5 adults with class II-III obesity (BMI≥35kg/m2) planned for bariatric surgery will undergo functional imaging and neurobehavioural tasks before bariatric surgery.

Refined protocol phase:

20 overweight adults (BMI≥30kg/m2 or BMI≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia)), referred for obesity treatment (surgical or non-surgical).

Combination of 3 neurobehavioural tasks:

Task 1 consists in subjective value rating of 64 food items. Participants are asked to rate how much they would want to eat the presented food item while fMRI (functional magnetic resonance imaging ) scanning is performed.

Task 2 consists in rating of subjective nutrient factor of the same 64 food items. Participants will answer the following four categorical questions in randomized order for each item: low or high in added sugar/protein/fat and healthy or unhealthy.

Task 3 consists of a decision-making task. Participants will be presented with two food items (out of the 64 food items), and asked to choose which of the two items they prefer to consume at the end of the experiment.

Control group (group 2)

Pilot phase:

5 healthy adults with normal body mass (BMI 18.5-24.9kg/m2) matched for age-, sex- and education will serve as a control group and undergo the same experiment.

Refined protocol:

20 healthy adults with normal body mass (BMI 18.5-24.9kg/m2) matched for age and sex will serve as a control group and undergo the same experiment.

Combination of 3 neurobehavioural tasks:

Task 1 consists in subjective value rating of 64 food items. Participants are asked to rate how much they would want to eat the presented food item while fMRI (functional magnetic resonance imaging ) scanning is performed.

Task 2 consists in rating of subjective nutrient factor of the same 64 food items. Participants will answer the following four categorical questions in randomized order for each item: low or high in added sugar/protein/fat and healthy or unhealthy.

Task 3 consists of a decision-making task. Participants will be presented with two food items (out of the 64 food items), and asked to choose which of the two items they prefer to consume at the end of the experiment.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Representational similarity analysis to assess neural encoding of food attributes
大体时间:Continuously while participants perform the tasks (during 2.5 hours)
Representational similarity analysis is used to analyse the correlation between a voxel-wise representational dissimilarity matrix and a behavioural representational dissimilarity matrix. The correlation of the activity of each voxel for each pair of food items is used to define the voxel-wise representational dissimilarity matrix. Similarly, the correlation of the subjective ratings for each pair of food items is used to define the behavioural representational dissimilarity matrix. The correlation between the voxel-wise representational dissimilarity matrix and the behavioural representational dissimilarity matrix is then assessed to determine if the voxels are encoding the food attributes.
Continuously while participants perform the tasks (during 2.5 hours)
Nutrient factor weights
大体时间:Continuously while participants perform the tasks (during 2.5 hours)
The nutrient factor weights are estimated using a linear regression with the subjective value ratings as dependent variable and nutrient factors ratings as independent variables and using a logistic regression with the choice as a dependent variable and the nutrient factor ratings as independent variables.
Continuously while participants perform the tasks (during 2.5 hours)

次要结果测量

结果测量
措施说明
大体时间
Differences in activity in neural areas involved in self-control and valuation (Dorsolateral prefrontal cortex (dlPFC), ventromedial prefrontal cortex (vmPFC), orbitofrontal cortex (OFC), anterior cingulate cortex (ACC), insula, hippocampus)
大体时间:Continuously while participants perform the tasks (during 2.5 hours)
Activity in the neural areas will be compared between groups
Continuously while participants perform the tasks (during 2.5 hours)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月12日

初级完成 (实际的)

2022年9月5日

研究完成 (实际的)

2022年9月5日

研究注册日期

首次提交

2021年1月18日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月24日

研究记录更新

最后更新发布 (实际的)

2022年9月23日

上次提交的符合 QC 标准的更新

2022年9月22日

最后验证

2022年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BrainFood Part 1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

To support the development of transparent and open science, the data collected during this study can be published in open science repositories (e.g., Open Science Framework) or with the research articles after acceptance of the research articles. The data will be pseudo-anonymized prior to their publication and the faces will be removed from MRI scans to ensure anonymity.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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