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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- BOLD signal change after SG
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
BOLD signal change after SG
时间窗: 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.
次要结局
- BOLD signal change after lifestyle intervention(average of 12 weeks)
- Correlation of taste responses and gut hormones(6 months)
- Brain structure 6 months following SG(6 months)
- BOLD signal in response to taste in severe obesity compared to normal weight(baseline)
- Brain structure(Baseline)
- BOLD signal change post-SG(6 months)
- Brain structure after 10% weight loss(approximately 6 weeks for SG group and approximately 12 weeks for lifestyle intervention group)