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- Ensayo clínico NCT03547063
Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour (TASTER)
15 de enero de 2021 actualizado 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).
Descripción general del estudio
Estado
Suspendido
Condiciones
Descripción detallada
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 estudio
De observación
Inscripción (Anticipado)
75
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
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London, Reino Unido, NW1 2BU
- University College London Hospital
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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 a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
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
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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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
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Lifestyle Intervention
25 participants, male and female, aged 18-50 years, BMI 35-50 kg/m2
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Normal Weight
25 participants, aged 18-50 years BMI 18.5-24.9
kg/m2, age and gender matched to group with severe obesity
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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BOLD signal change after SG
Periodo de tiempo: approximately 6 weeks
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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.
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approximately 6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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BOLD signal change after lifestyle intervention
Periodo de tiempo: average of 12 weeks
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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.
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average of 12 weeks
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BOLD signal in response to taste in severe obesity compared to normal weight
Periodo de tiempo: baseline
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Brain responses, as BOLD signal, to taste in the fed and fasted state in severe obesity compared to normal weight
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baseline
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BOLD signal change post-SG
Periodo de tiempo: 6 months
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Whole brain neural response in BOLD signal to taste, in the fed and fasted state, 6 months following SG versus normal weight
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6 months
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Correlation of taste responses and gut hormones
Periodo de tiempo: baseline
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The relationship between the neural correlates of taste and levels of circulating gut hormones in severe obesity compared to normal weight
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baseline
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Correlation of taste responses and gut hormones
Periodo de tiempo: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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The relationship between the neural correlates of taste and levels of circulating gut hormones after 10% weight loss by SG compared to lifestyle intervention
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approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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Correlation of taste responses and gut hormones
Periodo de tiempo: 6 months post-SG compared to baseline
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The relationship between the neural correlates of taste and circulating gut hormone levels
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6 months post-SG compared to baseline
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Correlation of taste responses and gut hormones
Periodo de tiempo: 6 months
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The relationship between the neural correlates of taste and levels of circulating gut hormones post-SG compared to normal weight
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6 months
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Brain structure
Periodo de tiempo: Baseline
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Comparison of brain structure in severe obesity and normal weight
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Baseline
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Brain structure 6 months following SG
Periodo de tiempo: 6 months
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Comparison of brain structure 6 months following SG to baseline
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6 months
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Brain structure after 10% weight loss
Periodo de tiempo: approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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Comparison of brain structure following 10% weight loss induced by SG versus lifestyle intervention
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approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rachel L Batterham, PhD FRCP, UCL
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
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)
18 de diciembre de 2018
Finalización primaria (Anticipado)
1 de diciembre de 2021
Finalización del estudio (Anticipado)
1 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2018
Publicado por primera vez (Actual)
6 de junio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
15 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 18/0233
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
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. .