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临床试验/NCT03135132
NCT03135132已完成不适用

Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss

Yonsei University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6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
100
试验地点
2
主要终点
Visceral fat area at L4 (CT)

研究概览

简要总结

To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

详细描述

Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to give informed consent
  • 20-65 years old
  • Males and females
  • Overweight (25.0 kg/m²≤ Body mass index <30 kg/m²)
  • Nondiabetic (Fasting glucose <126 mg/dL)

排除标准

  • Unstable body weight (body weight change >1 kg within 3 months before screening)
  • Consumption of medication that affects body weight or energy expenditure
  • Pregnancy or breast-feeding
  • Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
  • Liver disease, kidney disease, or gastrointestinal disease
  • Acute or chronic infections
  • Any acute or chronic disease requiring treatment

结局指标

主要结局

Visceral fat area at L4 (CT)

时间窗: At 12-week follow-up

Change in visceral fat area at L4 from baseline

时间窗: At baseline and 12-week follow-up

Putatively identified plasma metabolites (Normalized peak intensities)

时间窗: At 12-week follow-up

Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline

时间窗: At baseline and 12-week follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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