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临床试验/NCT02885935
NCT02885935已完成不适用

Dairy Macronutrient Effects on the Metabolic Syndrome

University of Arkansas0 个研究点目标入组 12 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
主要终点
Changes in rate of glucose disappearance

研究概览

简要总结

The investigators examined the effects of 4-week dietary protein intake in mixed meals at two levels of protein amount on whole body glucose metabolisms in older adults with metabolic syndrome.

详细描述

The investigators investigated changes in insulin sensitivity before and after 4 weeks of dietary intervention and control in subjects with metabolic syndrome. Two groups of subjects were studied before and after a weight maintenance diet. Group 1 was fed a common American diet with a macronutrient distribution of 10% protein, 55% carbohydrates, and 35% fat. Group 2 consumed a higher protein diet (20%; 1.4 g/kg/d of protein). Carbohydrate intake was lower in Group 2 (45%), with fat intake (largely derived from dairy sources) similar between groups. Glucose utilization and endogenous glucose production were determined during an oral glucose tolerance test (OGTT) with a novel double-tracer approach. The secondary aim was to determine the effect of a diet high in dairy consumption on blood lipid profiles. The investigators measured blood lipids before and after dietary intervention in each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women, ages 45-75 years AND
  • BMI greater than 30 kg/m2 AND
  • Two of the following conditions:
  • Plasma triglycerides > 130 mg/dl
  • HDL < 40 mg/dl in men or 50 mg/dl in women
  • elevated screening blood pressure (systolic > 140 or diastolic >90 mm Hg) or taking medication for hypertension
  • fasting plasma glucose > 100mg/dl

排除标准

  • Hemoglobin A1c > 7.5
  • History of malignancy in the 6 months prior to enrollment
  • History of lactose intolerance or dairy allergy
  • History of gastrointestinal bypass surgery (Lapband, etc)
  • History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
  • Subjects who do not or will not eat animal proteins
  • Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
  • Subjects who use insulin to control their blood sugar
  • Subjects whose physician will not allow suspension of oral diabetes medications for the duration of the study (~5 weeks)
  • Concomitant use of corticosteroids (ingestion, injection or transdermal)
  • Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

结局指标

主要结局

Changes in rate of glucose disappearance

时间窗: Change from baseline and after 4weeks of dietary intervention

Rate of glucose disappearance from plasma to body tissues is a measure of whole body insulin sensitivity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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