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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07923513
Compulsive Eating and Brain's Reward System in Different Pathologies (BI-POTATOS)
Bipolar Disorders, Parkinson's Disease, ObesiTy and Compulsive eAting: TransnosOlogical Assessement of the Brain's Reward System
Compulsive eating behaviors represent a significant issue across various disorders such as Parkinson's disease, bipolar disorders, and obesity.
Despite their apparent differences, these conditions share common underlying disturbances involving the brain's reward system, particularly within dopaminergic networks.6,7 Previous neuroimaging studies have consistently reported reward system connectivity impairment associated with compulsive eating, in each of these disorders. However, few studies have simultaneously explored the neurobiological similarities and specificities of this common symptom, eating behavior, when occurring in different populations and disorders.
The Bi-POTATOS project proposes an original and innovative approach by adopting a transdiagnostic perspective, employing brain imaging and comprehensive psycho-behavioral assessments to investigate common behavioral characteristics and neural circuit alterations associated with compulsive eating across these three conditions. For the first time, this study will allow a direct comparison of the cerebral signatures linked to compulsive eating behavior, clearly distinguishing between transdiagnostic vulnerabilities and features unique to each clinical condition.
The central hypothesis is that similar dysfunctions in brain regions involved in motivation and impulsive decision-making underpin compulsive eating behaviors, irrespective of the initial diagnosis. However, the underlying pathology may modulate these mechanisms, introducing certain specificities.
By clarifying these common mechanisms, the Bi-POTATOS project will not only enhance our understanding of the neurobiological etiology of these disorders but also pave the way for innovative, targeted therapeutic interventions. This project will precisely identify whether specific neural alterations constitute a universally relevant therapeutic target, or conversely, determine which alterations necessitate tailored therapeutic strategies based on the underlying pathology.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Lise Laclautre
- Número de telefone: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Locais de estudo
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Clermont-Ferrand, França, 63000
- CHU de Clermont-Ferrand
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Contato:
- Lise Laclautre
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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1-Common Criteria (Parkinson disease, Obesity, Bipolar patients)
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Men or women, right-handed, 18 to 80 years old
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With or without compulsive eating according to the QEWP-R
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No changes to long-term treatments in the previous month
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Cooperation and understanding to strictly comply with the conditions set out in the protocol
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Acceptance of the protocol and signing of a written informed consent
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Affiliation to the social security system
2-Specific criteria Parkinsonian patients (n=25 with CE, n=25 without CE)
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Diagnosis of Parkinson's disease according to the Movement Disorders Society criteria
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BMI<30
Obese patients (n=25 with CE, n=25 without CE)
- Obese patients according to HAS 2022 classification
- BMI≥30
Bipolar patients (n=25 with CE, n=25 without CE)
- Diagnosis of bipolar disorder according to DSM 5 criteria
- BMI<30
Exclusion Criteria:
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1-Common Criteria
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Dementia (MoCA <22)
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Severe depression (Beck Depression Inventory>30)
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Contraindications to MRI (implanted stimulator, insulin pump, intraocular metallic foreign bodies or close to the nervous and vascular systems, claustrophobia, non-removable dental appliance, tattoo on the face or neck, …)
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Refusal to be informed in case of incidental finding on MRI
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History of stroke or brain trauma that may impact MRI findings
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Patients under guardianship, deprived of freedoms or protection of justice.
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Pregnant women, breastfeeding women
2- Specific criteria
Parkinsonian patients:
- People suffering from neurological pathologies other than PD
- Patient suffering from psychiatric disorder
- Treated with deep brain stimulation
- Patients with severe tremor (> 3 for a tremor sub-item of the MDS-UPDRS III) or excessively severe dyskinesia contraindicating MRI
Obese patients:
- Suffering from progressive neurological pathology and psychiatric disorder
- Weight >220kg contraindicating MRI
- Body (Shoulder) diameter > 220 cm contraindicating MRI
- History of bariatric surgery
- GLP1 treatment
Bipolar patients:
- Suffering from neurological pathology and psychiatric disorder other than bipolar disorder
- Current acute depressive or hypomanic episode according to DSM 5
- Treated with deep brain stimulation or vagus nerve stimulation
- Electroconvulsivotherapy < 6 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Study Group
Visit 1 : selection visit
Visit 2 : investigational visit
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Neuropsychological assessment : motor impulsivity, motor inhibition, cognitive impulsivity (Stroop); decision making in an ambiguous context (Iowa Gambling Task), time perception (delay discounting reward task) and risk taking (Balloon analog Risk task). MRI : The subjects will be scanned using a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil Dietician : 3 days food record
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Assessment of resting state seed-based functional connectivity from the limbic striatum (seed: ventral striatum) by MRI.
Prazo: At visit 2, between 1 and 12 weeks after patient enrollment
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MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil. The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise. The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm. Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes). |
At visit 2, between 1 and 12 weeks after patient enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Demographical data
Prazo: at visit 1, selection visit - Day 0
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sex |
at visit 1, selection visit - Day 0
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Demographical data
Prazo: at visit 1, selection visit - Day 0
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Age (year) |
at visit 1, selection visit - Day 0
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Demographical data
Prazo: at visit 1, selection visit - Day 0
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weight (kg) |
at visit 1, selection visit - Day 0
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Demographical data
Prazo: at visit 1, selection visit - Day 0
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size (m) |
at visit 1, selection visit - Day 0
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Parkinson Disease severity
Prazo: at visit 1, selection visit - Day 0
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Assessment of parkinson desease with the MDS-UPDRS (Movement Disorders Society - Unified Parkinson's Disease Rating Scale ) scale, completed by the investigator. |
at visit 1, selection visit - Day 0
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Bipolar Disease severity
Prazo: at visit 1, selection visit - Day 0
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Assessment of bipolar desease with MADRS (Montgomery-Asberg Depression Rating Scale) and YMRS (Young Mania Rating Scale) scale, completed by the investigator. |
at visit 1, selection visit - Day 0
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Obesity disease severity
Prazo: at visit 1, selection visit - Day 0
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Obesity classification according to Health French Agency (Haute Autorité de Santé) 2022, completed by the investigator. |
at visit 1, selection visit - Day 0
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Impulsive trait of Personality according the Barratt impulsiveness scale (BIS-11)
Prazo: at visit 1, selection visit - Day 0
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This self questionnaire is completed by the patient during the selection visit |
at visit 1, selection visit - Day 0
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Eating behavior disorder severity
Prazo: at visit 1, selection visit - Day 0
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Self reported eating behavior disorder using 3 questionnaires (QEWP5 (Questionnaire on Eating and Weight Patterns5), DEBQ (Dutch Eating Behaviour Questionnaire) and food craving questionnaire)) |
at visit 1, selection visit - Day 0
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Presence of Anxiety and/or depression according the Beck depression and anxiety scale
Prazo: at visit 1, selection visit - Day 0
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These self questionnaires is completed by the patient during the selection visit |
at visit 1, selection visit - Day 0
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Presence of restless legs syndrome according the International Restless Legs Syndrome (Rating Scale)
Prazo: at visit 1, selection visit - Day 0
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This questionnaire is completed by the investigator during the selection visit |
at visit 1, selection visit - Day 0
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Intensity and Pain caracteristics
Prazo: at visit 1, selection visit - Day 0
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Patients will evaluate their pain using 2 self questionnaires (3-PDQ, BPI (Brief Pain Inventory)) |
at visit 1, selection visit - Day 0
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Impulsive compulsive behaviors rating scale for PD (QUIP-RS)
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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The QUIP-RS is a brief 28-item patient-reported or clinician-rated scale developped for measure of severity of ICDs. Each item is rated on a 5-point Likert scale assessing frequency of symptoms with a range of scores from 0 (never) to 4 (very often). |
at visit 2, between 1 and 12 weeks after selection visit
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Spontaneous food intake
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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Patients will report thier spontaneous food intake for 3 days using a dietary data collected. Patient nutritional intakes will be analysed using Nutrilog software |
at visit 2, between 1 and 12 weeks after selection visit
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Motor impulsivity (Go/No Go task)
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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Motor impulsivity will be assessed with the Go/No-go task. It is a simple experimental paradigm that requires participants to respond as quickly as possible (Go) to a particular class of stimuli, for example by pressing a key on a keyboard, and not to respond to other classes of stimuli (No Go). The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials. |
at visit 2, between 1 and 12 weeks after selection visit
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Motor inhibition (Stop Signal Task (SST))
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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The Stop Signal Task (SST) is a test that measures motor inhibition. The participant must respond quickly to Go stimuli but interrupt their response when a stop signal appears. The key index, the Stop Signal Reaction Time (SSRT), reflects the time required to stop an ongoing action. This test will be performed by neuropsychologist. |
at visit 2, between 1 and 12 weeks after selection visit
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Iowa Gambling Task (IGT)
Prazo: at visit 2, between 1 and 12 weeks after selection visit.
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IGT assesses risk-based learning by relying on a system of rewards and punishments within a simulated context of uncertainty, representing a real-life decision-making situation. Participants choose cards from four decks, each associated with varying amounts of monetary gains and losses. Over time, advantageous decks yield higher net rewards, while disadvantageous decks lead to net losses. Performance on the task reflects an individual's capacity to balance immediate rewards against long-term outcomes, thereby providing insight into adaptive decision-making and risk evaluation processes. This test will be performed by neuropsychologist. |
at visit 2, between 1 and 12 weeks after selection visit.
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Cognitive impulsivity (Stroop)
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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The Stroop Test is a cognitive task designed to evaluate attentional control and the ability to inhibit automatic responses when faced with conflicting information. Participants are asked to name the color of the ink in which words are printed, even when the word itself refers to a different color (e.g., GREEN printed in red ink). This requires suppressing the automatic tendency to read the word and instead focusing on the ink color. The difference in performance between congruent and incongruent conditions, known as the Stroop interference effect, is a key indicator of cognitive inhibition and executive control. This test will be performed by neuropsychologist. |
at visit 2, between 1 and 12 weeks after selection visit
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Time perception (delay discounting reward task)
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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Participants make choices between two alternatives: a larger reward available after a delay (across seven delay intervals) and a smaller reward available immediately. The value of the immediate reward is systematically adjusted, either increasing or decreasing, in separate blocks. The task assesses preferences for immediate versus delayed gratification using two reward types: money and food. This test will be performed by neuropsychologist. |
at visit 2, between 1 and 12 weeks after selection visit
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Balloon analog Risk task
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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Participants are given 30 balloons (by default). For each balloon, they can choose either to inflate it further or to collect their earnings. With each successful inflation, they can earn money. However, if a balloon bursts before the participant collects the potential earnings, they lose all potential gains associated with that balloon. The average number of pumps on balloons that do not burst is the primary dependent variable in this paradigm. A higher number of pumps reflects increased risk-taking behavior. This test will be performed by neuropsychologist. |
at visit 2, between 1 and 12 weeks after selection visit
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Surface based (Freesurfer) and Voxel based (SPM) morphometry performed by MRI
Prazo: at visit 2, between 1 and 12 weeks after selection visit
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MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil. The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise. The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm. Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes). |
at visit 2, between 1 and 12 weeks after selection visit
|
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Structural connectivity (MRtrix and TRACTseg) performed by MRI
Prazo: at visit 2, between 1 and 12 weeks after selection visit
|
MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil. The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise. The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm. Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes). |
at visit 2, between 1 and 12 weeks after selection visit
|
|
Resting state seed-based functional connectivity from the limbic striatum performed by MRI
Prazo: at visit 2, between 1 and 12 weeks after selection visit
|
MRI is a 3-Tesla MAGNETOM Vida scanner (Siemens, Erlangen, Germany) with a 64 channel head coil. The subjects were asked to hold still, with their eyes open and not to think of anything particular. Foam padding was employed to reduce head movement and earplugs were used to reduce scanner noise. The high resolution anatomical images were obtained through a T1-weighted magnetization-prepared rapid gradient echo (MPRAGE) sequence with the following parameters: repetition time (TR): 2300 ms, echo time (TE): 3.08 ms, inversion time (IT): 900 ms, flip angle (FA): 9°, matrix: 288 x 288, 176 slices, slice thickness: 1mm. Resting-state functional MRI images were obtained using an EPI sequence with the following parameters: TR: 3000ms, TE: 30ms, FA: 81°, field of view (FOV): 192 mm, 55 slices, slice thickness: 3.3 mm, gap between slices: 3.3 mm, pixel bandwidth: 2441 Hz/Pixel, number of time points: 180, acquisition duration: 9 minutes). |
at visit 2, between 1 and 12 weeks after selection visit
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sinucleinopatias
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Doenças Neurodegenerativas
- Distúrbios do Movimento
- Excesso de peso
- Distúrbios parkinsonianos
- Doenças dos Gânglios da Base
- Comportamental, Viciante
- Comportamento compulsivo
- Comportamento impulsivo
- Alimentação e Distúrbios Alimentares
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Vício em comida
- Obesidade
- Doença de Parkinson
- Técnicas de investigação
- Instalações de saúde Força e serviços de trabalho
- Pessoal de saúde
- Técnicas de química, analíticas
- Análise de espectro
- Espectroscopia de ressonância magnética
- Nutricionistas
Outros números de identificação do estudo
- AOI 2025 MARQUES
- 2026-A00850-51 (Outro identificador: ANSM)
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