Calorie Restriction, Protein Supplementation and Metabolic Health (CRPS)
2017年3月22日 更新者：Washington University School of Medicine
Calorie Restriction and Metabolic Health
The purpose of this study is to determine whether consuming additional protein during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
75
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
-
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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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
50年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Obese with body mass index (BMI) between 30 and 50 kg/m2
- Postmenopausal
- Sedentary (i.e., less than 1.5 hours of exercise per week)
Exclusion Criteria:
- Individuals with diabetes and/or uncontrolled hypertension
- Individuals with hepatitis B and/or C
- Individuals who smoke
- Individuals with an allergy to whey protein
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 |
|---|---|
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有源比较器：正常蛋白质摄入量减轻体重
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Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).
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无干预：Weight maintenance
Weight maintenance with normal protein intake
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实验性的：Weight loss with protein supplementation
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Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day).
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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 |
|---|---|---|
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Change in muscle volume
大体时间：Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Thigh muscle volume will be measured by magnetic resonance imaging (MRI)
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Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Change in muscle strength
大体时间：Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Muscle strength will be evaluated by administering maximum one repetition strength and isokinetic strength tests.
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Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Changes in bone mineral density and bone mineral content
大体时间：Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Total bone mass and total body and regional bone mineral density will be evaluated by using dual X-ray energy absorptiometry (DXA).
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Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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粪便中细菌数量的变化
大体时间：卡路里限制组的基线和 10% 体重减轻以及体重维持组约 6 至 7 个月
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卡路里限制组的基线和 10% 体重减轻以及体重维持组约 6 至 7 个月
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Change in insulin sensitivity
大体时间：Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Insulin sensitivity (glucose rate of disappearance [Rd] during a hyperinsulinemic-euglycemic clamp procedure) will be evaluated in a subset of 10 participants per group because power analysis has determined that this number is sufficient to detect a 25% difference between groups assuming 80% power, an alpha value of 0.05 and an average baseline insulin-stimulated glucose Rd of 2,590 ± 492 µmol/min, the average ± SD insulin stimulated glucose Rd the investigators have measured during the past 20 y in obese subjects.
In the investigators' experience (Kirk et al., 2009 and Magkos et al., 2016), the weight loss induced increase in insulin stimulated glucose Rd is ~50%.
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Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Change in muscle protein metabolism
大体时间：Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group
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Rates of muscle protein synthesis, breakdown and net protein balance will be assessed during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated.
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Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group
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Change in cell proliferation (growth) rates in the colon
大体时间：Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
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Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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Determine the acute effect of whey protein ingestion on skeletal muscle insulin sensitivity
大体时间：Prior to starting the weight loss or maintenance intervention
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Insulin sensitivity will be evaluated using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
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Prior to starting the weight loss or maintenance intervention
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Determine the acute effect of whey protein ingestion on muscle protein metabolism
大体时间：Prior to starting the weight loss or maintenance intervention
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Rates of muscle protein synthesis, breakdown and net protein balance will be assessed using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without whey protein ingestion
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Prior to starting the weight loss or maintenance intervention
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kirk E, Reeds DN, Finck BN, Mayurranjan SM, Patterson BW, Klein S. Dietary fat and carbohydrates differentially alter insulin sensitivity during caloric restriction. Gastroenterology. 2009 May;136(5):1552-60. doi: 10.1053/j.gastro.2009.01.048. Epub 2009 Jan 25. Erratum In: Gastroenterology. 2009 Jul;137(1):393. Mayurranjan, Mitra S [corrected to Mayurranjan S Mitra].
- Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. Epub 2014 Dec 4.
- Harris LLS, Smith GI, Patterson BW, Ramaswamy RS, Okunade AL, Kelly SC, Porter LC, Klein S, Yoshino J, Mittendorfer B. Alterations in 3-Hydroxyisobutyrate and FGF21 Metabolism Are Associated With Protein Ingestion-Induced Insulin Resistance. Diabetes. 2017 Jul;66(7):1871-1878. doi: 10.2337/db16-1475. Epub 2017 May 4.
- Magkos F, Bradley D, Eagon JC, Patterson BW, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on gastrointestinal metabolism of ingested glucose. Am J Clin Nutr. 2016 Jan;103(1):61-5. doi: 10.3945/ajcn.115.116111. Epub 2015 Nov 25.
- Smith GI, Yoshino J, Kelly SC, Reeds DN, Okunade A, Patterson BW, Klein S, Mittendorfer B. High-Protein Intake during Weight Loss Therapy Eliminates the Weight-Loss-Induced Improvement in Insulin Action in Obese Postmenopausal Women. Cell Rep. 2016 Oct 11;17(3):849-861. doi: 10.1016/j.celrep.2016.09.047.
- Smith GI, Patterson BW, Klein SJ, Mittendorfer B. Effect of hyperinsulinaemia-hyperaminoacidaemia on leg muscle protein synthesis and breakdown: reassessment of the two-pool arterio-venous balance model. J Physiol. 2015 Sep 15;593(18):4245-57. doi: 10.1113/JP270774. Epub 2015 Aug 14.
- Smith GI, Commean PK, Reeds DN, Klein S, Mittendorfer B. Effect of Protein Supplementation During Diet-Induced Weight Loss on Muscle Mass and Strength: A Randomized Controlled Study. Obesity (Silver Spring). 2018 May;26(5):854-861. doi: 10.1002/oby.22169.
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 (实际的)
2012年1月1日
初级完成 (实际的)
2017年3月1日
研究完成 (实际的)
2017年3月1日
研究注册日期
首次提交
2012年2月20日
首先提交符合 QC 标准的
2012年2月20日
首次发布 (估计)
2012年2月24日
研究记录更新
最后更新发布 (实际的)
2017年3月27日
上次提交的符合 QC 标准的更新
2017年3月22日
最后验证
2017年3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.