The Effect of High Protein Diets on Weight Loss and Lean Muscle Mass in Patients Awaiting Bariatric Surgery
2017年10月26日 更新者:Andrew MacCormick、University of Auckland, New Zealand
All patients in CMDHB eligible for bariatric surgery are given a weight loss goal prior to surgery.
It is unknown what the most effective diet is to lose weight, while still preserving muscle mass.
The diet must also be acceptable and adhered to by patients.
The aim of this study is to find out if a diet that is higher in protein and lower in carbohydrate than the standard Ministry of Health guidelines will have a greater effect on weight loss, preservation of lean muscle mass, surgical recovery score, adherence and acceptability.
研究概览
详细说明
This pilot project is a randomised control trial with 24 participants.
Diets will consist of 1200 and 1500kcals for females and males, respectively.
The control arm is to receive the Ministry of Health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%).
The intervention arm is to be lower in carbohydrate (40%), higher in protein (30%), moderate fat (30%).
Participants will be required to continue the diet for at least 8 weeks while waiting for surgery.
At baseline and at eight weeks their weight, hip circumference, waist circumference, neck circumference and body composition measurements will be taken.
During their prescribed diet they are required to fill out a 3-day diet record.
At the end of eight weeks the participants will perform a twenty-four hour urine collect for urea and creatinine.
This will help determine adherence.
Post-surgery (21-28 days) they will be required to complete a surgical recovery questionnaire and the above measurements will be recorded again.
These data will be collected over a period beginning January 2015.
It is expected that the intervention arm will have greater weight loss and better preservation of muscle mass leading to a better surgical recovery score.
However because the intervention requires a higher intake of protein this may have an effect on adherence and acceptability in these participants.
There are no known adverse effects of the intervention diet in the short term.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Auckland、新西兰
- Counties Manukau District Health Board
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants in this study will be patients eligible for bariatric surgery under CMDHB. These participants must have a BMI greater than 35kg/m2 with co-morbidities or a BMI greater than 40kg/m2.
Exclusion Criteria:
- Patients will be excluded from study if they do not attend surgeon or dietitian appointments. To be included in this study patients must be English speaking and weigh under 200kg.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Control Standard Protein Diet
Control Arm Ministry of Health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%).
|
|
|
实验性的:Intervention High Protein Diet
Intervention Arm Percentage energy from carbohydrate (40%), protein (30%) and fat (30%).
|
The intervention diet is higher in protein than the control diet.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Weight
大体时间:After 8-weeks of diet and 21-28 days post bariatric surgery
|
Scales
|
After 8-weeks of diet and 21-28 days post bariatric surgery
|
|
Change in Total body muscle mass
大体时间:After 8-weeks of diet and 21-28 days post bariatric surgery
|
Biometric scales
|
After 8-weeks of diet and 21-28 days post bariatric surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical recovery score
大体时间:Surgical recovery score 21-28 days post surgery
|
SRS tool
|
Surgical recovery score 21-28 days post surgery
|
|
compliance
大体时间:8 weeks
|
urinary creatinine
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Andrew D MacCormick, FRACS、University of Auckland, New Zealand
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年5月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2015年5月26日
首先提交符合 QC 标准的
2015年12月11日
首次发布 (估计)
2015年12月16日
研究记录更新
最后更新发布 (实际的)
2017年10月27日
上次提交的符合 QC 标准的更新
2017年10月26日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.