PROOF: PROtein OverFeeding Effect on Body Weight (PROOF)
2021年8月23日 更新者:Leanne Redman、Pennington Biomedical Research Center
Dietary Protein Content Determines Weight Gain During High Fat Overfeeding
This study is designed to determine the effects of dietary protein content on overfeeding.
研究概览
详细说明
When body weight increases, the expenditure of energy increases as a mechanism to dissipate the excess calories. The role of diet composition in over-feeding/energy dissipation in humans is unknown. We propose that:
- High and low protein diet will result in less weight gain as compared to a moderate protein diet during a 56d high fat overfeeding.
- Increase in energy expenditure and spontaneous physical activity, adjusted for lean and fat mass will be greater in the high and low protein diets as compared to a moderate protein diet.
- the average size of the fat cells and the pattern of genes expressed in the adipose tissue, skeletal muscle, and peripheral blood mononuclear cells will "predict" which group of subjects will gain the most weight (and fat mass) independent of the level of the protein in the diet.
研究类型
介入性
注册 (实际的)
60
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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Louisiana
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Baton Rouge、Louisiana、美国、70808
- Pennington Biomedical Research 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
18年 至 35年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have a BMI of 19-30kg/m2 A cutpoint of 26kg/m2 will be used to allocate treatment across the three diets. See the statistics section for more detail.
- Are willing to eat all of the study foods even when full
- Are willing to eat only foods provided by Pennington and all of the foods provided
- Are willing to live at Pennington for 10-12 weeks possibly without leaving the metabolic unit the entire time
- Are willing to avoid exercise while in the inpatient phase of the study
- Age 18 - 35
Exclusion Criteria:
Participants are ineligible to participate in the study if they…
- Smoke
- Have Diabetes
- Have claustrophobia
- Have a Fasting Blood Sugar >110
- Have a history of cardiovascular disease
- Have an average screening blood pressure >140/90
- Have a history of a major psychiatric, addictive or eating disorder or any psychosocial or scheduling factors that could impede study outcomes
- Post obese (self-reported BMI) must never have had a BMI greater than 32
- Exercise more than 2 hours per week
- Unable to complete VO2 max test.
- Weight gain or loss of > 3kg in the last 6 months
- Have significant renal, hepatic, endocrine, pulmonary or hematological disease, or a history of gout
- Have had previous GI surgery, Obstructive disease of the GI tract, Hypermotility disorder or a history of problems of impairment of the gag reflex.
- Corticosteroid use in the last 2 Months
- You are pregnant or breastfeeding
- Have Irregular menstrual cycles
- Use Depo-Provera, hormone implant or estrogen replacement therapy
- Have an allergy to PABA (a component of a B-vitamin often found in sunscreen)
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Normal Protein (15%) diet
|
dietary overfeeding with high, low or normal protein content
其他名称:
|
实验性的:2
Low Protein (5%) diet
|
dietary overfeeding with high, low or normal protein content
其他名称:
|
实验性的:3
High Protein (25%) diet
|
dietary overfeeding with high, low or normal protein content
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To determine the effect of overfeeding 40% above energy balance with a low (5%) or high (25%) vs. normal (15%) protein diet on body weight and body composition as well as energy expenditure and its components.
大体时间:baseline and after 8 weeks of overfeeding
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baseline and after 8 weeks of overfeeding
|
次要结果测量
结果测量 |
大体时间 |
---|---|
To relate the baseline characteristics of the subjects [fat cell size, pattern of gene expression, body composition, family history of obesity, etc] to the degree of weight / fat gain during overfeeding.
大体时间:baseline and after 8 Weeks of over feeding
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baseline and after 8 Weeks of over feeding
|
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:Steven R Smith, MD、Pennington Biomedical Research Center
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
- Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
- Hochsmann C, Fearnbach N, Dorling JL, Myers CA, Zhang D, Apolzan JW, Stewart TM, Bray GA, Ravussin E, Martin CK. Effect of 8 weeks of supervised overfeeding on eating attitudes and behaviors, eating disorder symptoms, and body image: Results from the PROOF and EAT studies. Eat Behav. 2021 Dec;43:101570. doi: 10.1016/j.eatbeh.2021.101570. Epub 2021 Oct 1.
- Bray GA, Redman LM, de Jonge L, Rood J, Sutton EF, Smith SR. Plasma fatty acyl-carnitines during 8 weeks of overfeeding: relation to diet energy expenditure and body composition: the PROOF study. Metabolism. 2018 Jun;83:1-10. doi: 10.1016/j.metabol.2018.01.019. Epub 2018 Feb 8.
- Bray GA, Redman LM, de Jonge L, Rood J, Sutton EF, Smith SR. Plasma Amino Acids During 8 Weeks of Overfeeding: Relation to Diet Body Composition and Fat Cell Size in the PROOF Study. Obesity (Silver Spring). 2018 Feb;26(2):324-331. doi: 10.1002/oby.22087. Epub 2017 Dec 27.
- Sutton EF, Bray GA, Burton JH, Smith SR, Redman LM. No evidence for metabolic adaptation in thermic effect of food by dietary protein. Obesity (Silver Spring). 2016 Aug;24(8):1639-42. doi: 10.1002/oby.21541. Epub 2016 Jun 29.
- Bray GA, Redman LM, de Jonge L, Rood J, Smith SR. Effect of Three Levels of Dietary Protein on Metabolic Phenotype of Healthy Individuals With 8 Weeks of Overfeeding. J Clin Endocrinol Metab. 2016 Jul;101(7):2836-43. doi: 10.1210/jc.2016-1313. Epub 2016 May 9.
- Bray GA, Redman LM, de Jonge L, Covington J, Rood J, Brock C, Mancuso S, Martin CK, Smith SR. Effect of protein overfeeding on energy expenditure measured in a metabolic chamber. Am J Clin Nutr. 2015 Mar;101(3):496-505. doi: 10.3945/ajcn.114.091769. Epub 2015 Jan 14.
- Gilmore LA, Ravussin E, Bray GA, Han H, Redman LM. An objective estimate of energy intake during weight gain using the intake-balance method. Am J Clin Nutr. 2014 Sep;100(3):806-12. doi: 10.3945/ajcn.114.087122. Epub 2014 Jul 23.
- Bray GA, Smith SR, de Jonge L, Xie H, Rood J, Martin CK, Most M, Brock C, Mancuso S, Redman LM. Effect of dietary protein content on weight gain, energy expenditure, and body composition during overeating: a randomized controlled trial. JAMA. 2012 Jan 4;307(1):47-55. doi: 10.1001/jama.2011.1918. Erratum In: JAMA. 2012 Mar 14;307(10):1028.
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
2005年3月1日
初级完成 (实际的)
2008年3月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2007年11月27日
首先提交符合 QC 标准的
2007年11月27日
首次发布 (估计)
2007年11月29日
研究记录更新
最后更新发布 (实际的)
2021年8月25日
上次提交的符合 QC 标准的更新
2021年8月23日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
其他研究编号
- PBRC 25007
- 2005-34323-15741
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.