Measuring Eating, Activity and Strength: Understanding the Response -Using Protein (MEASUR-UP)
2018年12月10日 更新者：Duke University
Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight reduction intervention.
Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal.
Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from beef.
Subject criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)
研究概览
研究类型
介入性
注册 (实际的)
71
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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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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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
60年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 60+ yrs.
- BMI of >30 kg/m2
- Body weight <495 lbs.
- Normal blood chemistries
- Normal renal function
- Primary care physician acknowledgement
- Non-Vegetarian
- Mild to moderate movement impairment
Exclusion Criteria:
- Body weight >495 pounds.
- Current smoker.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Positive screen for dementia using Mini-Cog evaluation tool.
- Neurological conditions causing functional or cognitive impairments.
- History of significant weight instability (defined as > 10 pounds weight gain or loss over 6 months prior to study participation).
- Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months.
- Inability to walk independently.
- Bilateral hip replacements.
- Unable to give consent.
- Unable to complete written recording forms including journals of eating and exercise behaviors.
- Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications.
- Primary Care Physician advises against participation.
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Weight Loss Control
Diet counseling and group education lessons.
Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
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Individual and group diet counseling to achieve a >10% weight loss
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实验性的：Weight Loss-High Protein
Protein supplementation.
Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef.
Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.
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> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.
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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 Short Physical Performance Battery (SPPB)
大体时间：Baseline to 3 to 6 months
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short physical performance battery
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Baseline to 3 to 6 months
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Change in lean body mass
大体时间：Baseline to 3 and 6 months
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Bodpod
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Baseline to 3 and 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6 个月时基线三甲胺-N-氧化物 (TMAO) 的变化
大体时间：基线至 6 个月
|
TMAO 是由含有营养素的三甲胺 (TMA) 产生的代谢物。
核磁共振 (NMR) 光谱分析用于 TMAO 浓度的量化。
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基线至 6 个月
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6 个月时基线甜菜碱的变化
大体时间：基线至 6 个月
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使用 Vantera® NMR 临床分析仪（LabCorp, Raleigh, NC）通过 1 H-核磁共振 (NMR) 光谱测量甜菜碱。
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基线至 6 个月
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6 个月时基线脂蛋白胰岛素抵抗指数 (LP-IR) 评分的变化
大体时间：基线至 6 个月
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LP-IR 是一种复合代谢组学生物标志物，可捕捉胰岛素抵抗对脂蛋白代谢链的多维影响。
它通过核磁共振波谱测量为 VLDL、LDL 和 HDL 粒径及其子集浓度的加权分数。
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基线至 6 个月
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6 个月时基线空腹血糖的变化
大体时间：基线至 6 个月
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禁食至少 8 小时后血液中的葡萄糖水平
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基线至 6 个月
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Change in baseline lipids (classes, subclasses, participle size and number) at 6 months
大体时间：Baseline to 6 months
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Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) and subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm.
Mean VLDL, LDL and HDL particle sizes were weighted averages derived from the sum of the diameter of each subclass multiplied by its relative mass percentage.
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Baseline to 6 months
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Changes in baseline GlycA at 6 months
大体时间：Baseline to 6 months
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NMR-measured systemic inflammatory factor and a biomarker of CVD risk
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Baseline to 6 months
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Change in baseline branched chain amino acids (BCAA) at 6 months
大体时间：Baseline to 6 months
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NMR MetaboProfile analysis, which reports concentrations of several metabolites [ the branched chain amino acids (BCAA) valine, leucine, and isoleucine] was performed using the recently developed LP3 deconvolution algorithm.
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Baseline to 6 months
|
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Change in baseline GFR at 6 months
大体时间：Baseline to 6 months
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Estimated GFR, which measures renal filtering capacity, is a calculated value based on age, sex, race, and serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
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Baseline to 6 months
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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。
调查人员
- 首席研究员：Connie W Bales, PhD, RD、Duke University
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
- Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27.
- Payne ME, Porter Starr KN, Orenduff M, Mulder HS, McDonald SR, Spira AP, Pieper CF, Bales CW. Quality of Life and Mental Health in Older Adults with Obesity and Frailty: Associations with a Weight Loss Intervention. J Nutr Health Aging. 2018;22(10):1259-1265. doi: 10.1007/s12603-018-1127-0.
- Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.
- McDonald SR, Porter Starr KN, Mauceri L, Orenduff M, Granville E, Ocampo C, Payne ME, Pieper CF, Bales CW. Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial. Contemp Clin Trials. 2015 Jan;40:112-23. doi: 10.1016/j.cct.2014.11.010. Epub 2014 Nov 20.
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
2012年9月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2012年10月25日
首先提交符合 QC 标准的
2012年10月26日
首次发布 (估计)
2012年10月29日
研究记录更新
最后更新发布 (实际的)
2018年12月12日
上次提交的符合 QC 标准的更新
2018年12月10日
最后验证
2018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.