Body Composition and Energy Expenditure With Total Diet Replacement During Weight Loss and Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- WP2: metabolic adaptation during weight loss and maintenance
研究概览
简要总结
National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight loss maintenance can be achieved in around 33% of patients at 12 months.
The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet Replacement Plan (TDR) of 800+ Calories followed by structured Food Reintroduction, and Weight Loss Maintenance programmes.
The study will incorporate three work packages with the aim of:
- examining changes in body composition with substantial (target >15kg) non-surgical weight loss (work package 1, WP1)
- characterizing the metabolic adaptations during weight loss and maintenance (work package 2, WP2)
- examining Rescue Packages as a method of weight re-gain prevention (work package 3, WP3).
详细描述
All participants will receive the Counterweight Plus dietary intervention. This consists of:
- 12-20 weeks 800+ calories/day Total Diet Replacement Plan, followed by
- 6-8 weeks Food Reintroduction, followed by
- up to 104 weeks Weight Loss Maintenance, based on maintaining daily calorie restriction.
All participants will undergo the following investigations at baseline and at regular intervals throughout the study period:
- height (baseline only)
- whole body MRI scans: total-body skeletal muscle volume and fat mass will be measured using whole-body multi-slice MRI (baseline and 12 weeks only)
- functional assessment: completion of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (baseline and 12 weeks only)
- gait and muscle strength assessment: biomechanical gait analysis will be carried out using an 8 camera VICON system during flat walking to determine maximum flexion and extension moments for both limbs and maximum adduction and abduction moments. Muscle strength will also be directly measured of both the upper (grip strength) and lower (quadriceps and hamstrings) limb using a dynamometer and myometer (baseline and 12 weeks only)
- anthropometric measurement: body weight; waist, hip, thigh, arm and calf circumferences
- indirect calorimetry: resting metabolic rate will be measured by a computerised open-circuit ventilated hood system
- fasting blood sampling: for measurement of HbA1C, lipid profile, leptin, thyroid hormones
- gut microbiota analysis from faecal samples
- Binge Eating Disorder and Quality of Life (EQ-5D) questionnaires
Participants will receive regular support/advice from a research dietician/ nutritionist during the two year study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •confirmation from general practitioner (GP) of suitability for intervention
- •written informed consent
- •BMI ≥30 kg/m2 and < 45kg/m2, weight<200 kg and <60 cm bore size
排除标准
- •known illness such as heart disease, cancer, or any disability that would affect weight loss (diabetes not an exclusion) or prevent completion of the intervention
- •implanted electronic devices that are MRI incompatible or MRI unsafe, ferromagnetic foreign bodies
- •substance abuse
- •myocardial infarction within previous 6 months
- •learning difficulties and subjects having difficulty in understanding verbal or written English
- •pregnant/ considering pregnancy
- •patients who have required hospitalisation for depression or are on antipsychotic drugs
- •people currently participating in another clinical research trial
- •recent weight loss >5kg within the last 6 months
- •current treatment with anti-obesity drugs
- •diagnosed eating disorder
研究组 & 干预措施
Counterweight Plus Dietary Intervention
Weight management programme including total diet replacement with soups and shakes; approximately 800 calories/day
干预措施: Counterweight Plus (Dietary Supplement)
结局指标
主要结局
WP2: metabolic adaptation during weight loss and maintenance
时间窗: 2 years
Change in resting metabolic rate before and after weight loss
WP3: weight regain prevention
时间窗: 2 years
% achieving \>15kg weight loss at 12 and 24 months
WP1: change in body composition with substantial, non-surgical, weight loss
时间窗: 20 weeks
Measurement of muscle mass before and after a weight loss programme using MRI
次要结局
- Adherence and acceptability of Rescue Packages to Patients(2 years)
- Muscle/fat mass of specific muscle groups(20 weeks)
- Metabolic adaptive effect of weight loss(2 years)
- Weight regain prevention(2 years)