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临床试验/NCT02298725
NCT02298725已完成不适用

Individual Metabolism and Physiology Signature Study

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Change in Fasting Insulin Concentrations

研究概览

简要总结

To determine if consumption of different diet plans that both are nutritionally-adequate and provide energy to maintain body weight, alters fasting insulin concentrations, shifts other common clinical markers of metabolic disease risk, and affects metabolomic profiles that reflect glucose, lipid, and amino acid metabolism.

详细描述

Western Human Nutrition Research Center (WHNRC) scientists have observed rapid and substantial improvements in metabolic health indices in non-diabetic obese persons who undergo a weight-maintenance diet including prepared meals that were aligned with current dietary recommendations, including those of the Institute of Medicine and the United States Department of Agriculture (USDA) and Department of Health and Human Services (DHHS) Dietary Guidelines for Americans. For instance, marked reductions and often normalization of hyperinsulinemia were observed within days of provision of a controlled nutrient-dense high quality diet, and LDL was reduced by 20-30% or more within 2 weeks or possibly earlier. This indicates that change in diet alone would benefit many at-risk persons with respect to normalizing metabolic parameters and disease risk markers. Yet, surprisingly little formal research has focused on how a high quality, weight maintaining diet impacts health over a short-term period in at-risk individuals. The overall objective of this study is to determine if a nutrient-adequate diet closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans elicits a superior metabolic profile in persons at-risk for metabolic disease, compared to a nutrient-adequate containing foods closely aligned with the National Health and Nutrition Examination Survey (NHANES) "What We Eat In America" report. Further, the investigation will include effect modification of stress-related cortisol measures on change in cardiometabolic risk factors.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal by self-report
  • Body Mass Index 25-39.9 kg/m2
  • Fasting glucose ≥100 and <126 mg/dL and/or
  • Oral Glucose Tolerance Test (OGTT) 2-hour glucose ≥140 and <199 mg/dL and/or
  • Quantitative insulin sensitivity check index (QUICKI) score <0.315 and/or
  • Homeostasis Model Assessment (HOMA) >3.67, or log HOMA >0.085 and/or
  • Glycated Hemoglobin HbA1c ≥5.7 and <6.5fasting glucose ≥100 and <126 mg/dL and/or
  • Fasting triglyceride concentrations >150 mg/dL and/or
  • LDL cholesterol >100 mg/dL and/or
  • HDL cholesterol <40 mg/dL.

排除标准

  • BMI <25 and >39.9 kg/m2
  • Presence of any metabolic diseases, by self-report
  • Gastrointestinal disorders by self-report
  • Presence of cancer or other serious chronic disease by self-report
  • Current use of prescribed or over the counter weight loss medications
  • Lactating
  • Current use of tobacco
  • Moderate or strenuous physical activity >30 min/day, 5 or more days per week
  • Weight change >5% of body weight during the previous 6 months
  • Dietary restrictions that would interfere with consuming the intervention foods

结局指标

主要结局

Change in Fasting Insulin Concentrations

时间窗: Weeks 1, 3, and 9

Additional indicators of glucose-insulin sensitivity will be assessed including the Quantitative Insulin Sensitivity Check Index (QUICKI) score, Homeostasis Model Assessment (HOMA), and Matsuda Index

次要结局

  • Change in Lipid Profile(Weeks 1, 3, and 9)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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