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Dairy Attenuation of Metabolic Disease

2010年12月22日 更新者:University of Tennessee

Dairy Attenuation of Oxidative and Inflammatory Stress in Metabolic Syndrome

Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome will be randomized to inadequate dairy (<0.5 serving/day) and adequate dairy (3.5 servings/day) weight maintenance (eucaloric) diets for 12 weeks. Body weight will be measured weekly and body composition (via dual X-ray absorptiometry), insulin sensitivity index, plasma lipids and calcitrophic hormones will be measured at weeks 0, 4 and 12 of the dietary intervention. Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL and inflammatory stress will be assessed by measurement of IL-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α levels in plasma at 0, 1, 4 and 12 weeks). An additional global evaluation of diet-induced changes in cytokines will be conducted using cytokine protein arrays to profile relative changes in 36 additional potentially relevant cytokines. All data will be analyzed via two-factor (diet X obesity status) multivariate analysis of variance (MANOVA)

研究概览

详细说明

This study is designed to determine the effects of a dairy-rich diet on oxidative and inflammatory stress in metabolic syndrome patients in the presence and absence of obesity. Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome as defined by NCEP ATP III criteria will be randomized to inadequate (0-0.5 daily serving) or adequate (3.5 servings) dairy diets in the presence of a eucaloric weight maintenance diet for 12 weeks. All subjects will undergo a 14-day lead-in period to establish a stable baseline of dietary and physiological measures (described below), followed by the 12-week intervention period. Baseline dietary assessments will be conducted by the project dietitian during the two-week lead-in period which will be used to provide an initial estimate of a maintenance level of caloric intake. This will be refined by calculating energy needs using DRI equations for calculation of age- and physical activity (PA) adjusted total energy expenditure (TEE) for men and women. Energy requirements will be confirmed via measurement of resting metabolic rate via indirect calorimetry.

Subjects will be given diets isocaloric to those consumed during the lead-in period, with macronutrient and fiber levels maintained equivalent at levels approximating the estimated U.S. average (described in Diets section). Subjects on the inadequate dairy diets will be assigned diets containing < 600 mg Ca/day and <0.5 daily serving of dairy foods, and subjects on the adequate dairy diets will be assigned diets containing 1200 - 1400 mg Ca/day and 3.5 daily servings of dairy (milk, yogurt, hard cheese). Two of the three dairy servings consumed daily by those on the high dairy diet will be milk and/or yogurt to ensure sufficient consumption of whey proteins. All subjects will be provided individual instruction, counseling and assessment from the study dietitian regarding dietary adherence and the development and reinforcement of strategies for continued success, and diets will be monitored weekly. Physical activity will be assessed using pedometer counts and maintained at approximately pre-study levels throughout the study. Pedometer counts will be recorded daily for the 14-day lead-in period and the value averaged to provide a pre-study baseline. Subjects will be asked to maintain the same level of activity (plus or minus 500 steps/day) and will use pedometers for self-assessment. Pedometer counts will be recorded and provided to the study staff on a weekly basis, along with the diet records.

Body weight, waist circumference, and blood pressure will be measured weekly and body composition (via dual X-ray absorptiometry) will be measured at weeks 0, 4 and 12 of the dietary intervention. Resting metabolic rate and respiratory quotient will be assessed at weeks 0 and 12. Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL at weeks 0, 1, 4 and 12, and inflammatory stress will be assessed by measurement of IL-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α levels in plasma at the same time intervals. Glucose tolerance, HOMAIR, fasting plasma lipids, PTH and 1,25-(OH)2-D levels will be determined at the same time intervals (0, 4, and 12 weeks). All data will be analyzed via two-factor multivariate analysis of variance (MANOVA).

研究类型

介入性

注册 (实际的)

40

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

    • Tennessee
      • Knoxville、Tennessee、美国、37996
        • The University of Tennessee Nutrition and Metabolic Research Laboratory

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 50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:

  • • Diagnosis of metabolic syndrome as defined by NCEP ATP III criteria: Presence of three or more of the following risk determinants:

    • Abdominal obesity (This criterion must be met by all obese subjects entered into the study)

      • Waist circumference >102 cm for males
      • Waist circumference >88 cm for females
    • Triglycerides >150 mg/dL
    • HDL cholesterol <40 mg/dL (men); < 50 mg/dL (women)
    • Blood pressure >130/>85 mm Hg (This criterion must be met by all subjects [overweight and obese] entered into the study).
    • Fasting glucose >100 mg/dL

      • Body mass index (BMI) 25-39.9
      • Age 18-50 years
      • Weight stable: no more than 1 kg weight gain or loss during past four weeks

Exclusion Criteria:

  • • BMI < 25 or >40

    • Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
    • Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
    • history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
    • history of eating disorder
    • presence of active gastrointestinal disorders such as malabsorption syndromes
    • pregnancy or lactation
    • use of obesity pharmacotherapeutic agents within the last 6 months
    • use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 3 months
    • Chronic use of anti-inflammatory agents within the last four weeks
    • Use of antioxidant supplements within the last four weeks
    • Recent (current or past 12 weeks) use of any psychotropic medication
    • Recent (past four weeks) initiation of an exercise program
    • Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
    • Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
    • Recent (past 12-weeks) history of tobacco use

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:基础科学
  • 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
有源比较器:Low Dairy
<0.5 standard dairy servings/day
Less than 0.5 standard servings of dairy products per day
实验性的:Adequate dairy
3.5 standard dairy servings per day
3.5 standard servings of dairy foods per day

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
体重
大体时间:12周
12周
Body composition
大体时间:12 weeks
DEXA assessment
12 weeks
Oxidative Stress
大体时间:12 weeks
plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL
12 weeks
Inflammatory stress
大体时间:12 weeks
Plasma L-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α
12 weeks

次要结果测量

结果测量
措施说明
大体时间
血压
大体时间:12周
12周
脂质
大体时间:12周
12周
Insulin sensitivituy
大体时间:12 weeks
Glucose, insulin and HOMA
12 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:Michael B. Zemel, Ph.D.、The University of Tennessee

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。

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

2008年6月1日

初级完成 (实际的)

2009年4月1日

研究完成 (实际的)

2010年1月1日

研究注册日期

首次提交

2010年12月22日

首先提交符合 QC 标准的

2010年12月22日

首次发布 (估计)

2010年12月24日

研究记录更新

最后更新发布 (估计)

2010年12月24日

上次提交的符合 QC 标准的更新

2010年12月22日

最后验证

2010年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R011770040

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.

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