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

22 de septiembre de 2022 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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).

Tipo de estudio

De observación

Inscripción (Actual)

50

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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%)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Representational similarity analysis to assess neural encoding of food attributes
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de abril de 2021

Finalización primaria (Actual)

5 de septiembre de 2022

Finalización del estudio (Actual)

5 de septiembre de 2022

Fechas de registro del estudio

Enviado por primera vez

18 de enero de 2021

Primero enviado que cumplió con los criterios de control de calidad

19 de marzo de 2021

Publicado por primera vez (Actual)

24 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2022

Última verificación

1 de septiembre de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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