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临床试验/NCT03125356
NCT03125356已完成不适用

Low-calorie Sweeteners and Adipose Signaling

George Washington University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Transcriptomics

研究概览

简要总结

The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS) exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese adolescents and young adults. We will examine changes in gene expression in subcutaneous fat and will correlate these molecular changes with plasma biochemistry.

详细描述

The proposed study will investigate LCS-induced changes in metabolically "at-risk" young adults, under conditions that reflect typical beverage consumption. We will first identify molecular pathways potentially affected by LCS (adipose transcriptomics via global RNAseq) and then identify links between LCS-induced gene expression changes and circulating levels of key metabolic biomarkers and clinical outcomes. We will perform subcutaneous adipose biopsies before and after consumption of 12 ounces of diet soda three times daily for eight weeks. Within-subjects changes in adipose gene expression will be evaluated using RNAseq. We will then correlate transcriptomic changes with circulating levels of key inflammatory and metabolic biomarkers, to provide mechanistic insight into which pathways drive clinically-relevant LCS-induced metabolic impairments. We will measure glucose, insulin, inflammatory markers and adipose-derived hormones before and after eight weeks of LCS exposure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-25 years of age
  • Overweight and mild to moderate obesity (25 ≤ body mass index (BMI) <35 kg/m2)
  • Consumption of <1 food/beverage with sucralose and/or acesulfame-potassium per month
  • Able and willing to comply with all study procedures for the duration of the study

排除标准

  • Overt diabetes
  • Renal/gastrointestinal conditions
  • Pregnant/lactating
  • Recent significant weight change
  • Acute illness (w/fever)
  • Antibiotics in past 3 months
  • Use of illegal drugs/condition limiting ability to give consent.

结局指标

主要结局

Transcriptomics

时间窗: Pre/post 8 weeks of diet soda

Within-subjects changes in adipose gene expression will be evaluated using RNAseq

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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