- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03547063
Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour (TASTER)
15 de janeiro de 2021 atualizado por: University College, London
Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour: An fMRI Study Evaluating Brain Structure, Connectivity and Responses to Taste Across Different Body Weight Categories and in Response to Weight Loss
The aim of this study is to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals, using functional magnetic resonance imaging (fMRI).
Visão geral do estudo
Status
Suspenso
Condições
Descrição detalhada
This is an observational study aiming to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals using functional magnetic resonance imaging (fMRI).
Drops of liquid foods and a control solution will be delivered to the participants' mouth during fMRI scanning.
Body weight, gut hormones from serial blood samples, appetite scores and taste will be assessed at each study visit.
Tipo de estudo
Observacional
Inscrição (Antecipado)
75
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
London, Reino Unido, NW1 2BU
- University College London Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Participant groups:
Participants with severe obesity
- SG: 25 participants, male and female, aged 18-50 years, body mass index (BMI) 35-50 kg/m2, due to undergo primary SG.
- Lifestyle intervention: 25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2.
- Participants with normal weight: 25 participants, aged 18-50 years BMI 18.5-24.9 kg/m2, age and gender matched to group with severe obesity.
Descrição
Inclusion Criteria:
- Female and male adults aged 18-50 years.
- Right-handed.
- No MRI contra-indications.
- Weight stable at time of recruitment, defined as less than 5% variation in body weight over the preceding 3 months.
- Proficient in written and spoken English.
- Able to comply with study protocol.
- Willing and able to provide written informed consent.
- Participants must be registered with a general practitioner (GP).
- Willing for their treating consultant or their GP and the study team to be informed in the event of an incidental abnormal finding being detected by the investigations or assessments that form part of this study.
- Able to lie flat for 1 hour.
Group-specific inclusion criteria:
SG group:
- BMI of 35-50 kg/m2
- Planned to undergo primary SG surgery and fulfilling eligibility criteria for bariatric surgery.
Lifestyle intervention group:
- BMI of 35-50 kg/m2
- Willing to undergo a lifestyle intervention programme with a view to achieving approximately 10% weight loss.
Normal weight group:
- BMI 18.5-24.9 kg/m2
Exclusion Criteria:
- Body weight greater than 130kg (due to weight limit of MRI Scanner).
- Contraindications specific to MRI scanning: metallic implants (cardiac pacemakers, aneurysm clips, permanent eye lining, cochlear implants or anyone who has been exposed to metallic flakes or splinters).
- Type 1 and type 2 diabetes (in view of altered circulated gut hormone profiles and gustatory function).
- Menopause (in view of findings that the menopause affects gustatory function).
- Smoking (in view of the fact that smoking affects salivary gut hormones and gustatory function).
- Vitamin B12 or zinc deficiency (in view of deficiencies affecting gustatory function).
- Untreated severe depression.
- Eating disorders including bulimia and self-induced vomiting.
- Neurological or psychiatric conditions.
- Acute illness or chronic conditions that may impact upon gustatory and olfactory function.
- Acute illness or chronic conditions that may impact upon post-operative weight loss.
- Known or suspected history of HIV, Hepatitis B or C or other blood-borne diseases (in view of safety regulations regarding exposure to blood products)
- Pregnancy or lactation.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Sleeve Gastrectomy (SG)
25 participants, male and female, aged 18-50 years, body mass index (BMI) 35-50 kg/m2, due to undergo primary SG
|
|
Lifestyle Intervention
25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2
|
|
Normal Weight
25 participants, aged 18-50 years BMI 18.5-24.9
kg/m2, age and gender matched to group with severe obesity
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
BOLD signal change after SG
Prazo: approximately 6 weeks
|
To determine the effect of SG, at 10% weight loss, upon whole-brain neural response to taste, in the fed and fasted state, detected through blood-oxygen-level dependent (BOLD) signal, in patients with severe obesity.
|
approximately 6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
BOLD signal change after lifestyle intervention
Prazo: average of 12 weeks
|
The effect of 10% weight loss in patients with severe obesity induced by a lifestyle intervention on BOLD signal to taste in the fed and fasted state and compared to SG.
|
average of 12 weeks
|
|
BOLD signal in response to taste in severe obesity compared to normal weight
Prazo: baseline
|
Brain responses, as BOLD signal, to taste in the fed and fasted state in severe obesity compared to normal weight
|
baseline
|
|
BOLD signal change post-SG
Prazo: 6 months
|
Whole brain neural response in BOLD signal to taste, in the fed and fasted state, 6 months following SG versus normal weight
|
6 months
|
|
Correlation of taste responses and gut hormones
Prazo: baseline
|
The relationship between the neural correlates of taste and levels of circulating gut hormones in severe obesity compared to normal weight
|
baseline
|
|
Correlation of taste responses and gut hormones
Prazo: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
|
The relationship between the neural correlates of taste and levels of circulating gut hormones after 10% weight loss by SG compared to lifestyle intervention
|
approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
|
|
Correlation of taste responses and gut hormones
Prazo: 6 months post-SG compared to baseline
|
The relationship between the neural correlates of taste and circulating gut hormone levels
|
6 months post-SG compared to baseline
|
|
Correlation of taste responses and gut hormones
Prazo: 6 months
|
The relationship between the neural correlates of taste and levels of circulating gut hormones post-SG compared to normal weight
|
6 months
|
|
Brain structure
Prazo: Baseline
|
Comparison of brain structure in severe obesity and normal weight
|
Baseline
|
|
Brain structure 6 months following SG
Prazo: 6 months
|
Comparison of brain structure 6 months following SG to baseline
|
6 months
|
|
Brain structure after 10% weight loss
Prazo: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
|
Comparison of brain structure following 10% weight loss induced by SG versus lifestyle intervention
|
approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Rachel L Batterham, PhD FRCP, UCL
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Makaronidis JM, Neilson S, Cheung WH, Tymoszuk U, Pucci A, Finer N, Doyle J, Hashemi M, Elkalaawy M, Adamo M, Jenkinson A, Batterham RL. Reported appetite, taste and smell changes following Roux-en-Y gastric bypass and sleeve gastrectomy: Effect of gender, type 2 diabetes and relationship to post-operative weight loss. Appetite. 2016 Dec 1;107:93-105. doi: 10.1016/j.appet.2016.07.029. Epub 2016 Jul 22.
- Batterham RL, ffytche DH, Rosenthal JM, Zelaya FO, Barker GJ, Withers DJ, Williams SC. PYY modulation of cortical and hypothalamic brain areas predicts feeding behaviour in humans. Nature. 2007 Nov 1;450(7166):106-9. doi: 10.1038/nature06212. Epub 2007 Oct 14.
- Neseliler S, Han JE, Dagher A. The Use of Functional Magnetic Resonance Imaging in the Study of Appetite and Obesity. In: Harris RBS, editor. Appetite and Food Intake: Central Control. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2017. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK453146/
- Zhang Y, Ji G, Xu M, Cai W, Zhu Q, Qian L, Zhang YE, Yuan K, Liu J, Li Q, Cui G, Wang H, Zhao Q, Wu K, Fan D, Gold MS, Tian J, Tomasi D, Liu Y, Nie Y, Wang GJ. Recovery of brain structural abnormalities in morbidly obese patients after bariatric surgery. Int J Obes (Lond). 2016 Oct;40(10):1558-1565. doi: 10.1038/ijo.2016.98. Epub 2016 May 20.
- Goldstone AP, Miras AD, Scholtz S, Jackson S, Neff KJ, Penicaud L, Geoghegan J, Chhina N, Durighel G, Bell JD, Meillon S, le Roux CW. Link Between Increased Satiety Gut Hormones and Reduced Food Reward After Gastric Bypass Surgery for Obesity. J Clin Endocrinol Metab. 2016 Feb;101(2):599-609. doi: 10.1210/jc.2015-2665. Epub 2015 Nov 18.
- Faulconbridge LF, Ruparel K, Loughead J, Allison KC, Hesson LA, Fabricatore AN, Rochette A, Ritter S, Hopson RD, Sarwer DB, Williams NN, Geliebter A, Gur RC, Wadden TA. Changes in neural responsivity to highly palatable foods following roux-en-Y gastric bypass, sleeve gastrectomy, or weight stability: An fMRI study. Obesity (Silver Spring). 2016 May;24(5):1054-60. doi: 10.1002/oby.21464.
- Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
18 de dezembro de 2018
Conclusão Primária (Antecipado)
1 de dezembro de 2021
Conclusão do estudo (Antecipado)
1 de dezembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
11 de maio de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de maio de 2018
Primeira postagem (Real)
6 de junho de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de janeiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 18/0233
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .