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临床试验/NCT02094768
NCT02094768已完成不适用

Effects of Replacing Sugar Sweetened Beverages With Milk on Metabolic Factors in Overweight and Obese Adolescents

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
LDL peak particle diameter

研究概览

简要总结

Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Males, age 13-18
  • Tanner stage ≥ 2
  • Self reported sugar sweetened beverage intake 24oz to 60oz per day
  • Self reported milk intake ≤16 oz. per day
  • BMI 85-99 percentile for age
  • Tolerant to milk

排除标准

  • History or diagnosis of hypertension or taking blood pressure lowering medication
  • History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl
  • Fasting triglyceride > 300 mg/dl
  • On lipid lowering or diabetes medication

研究组 & 干预措施

Sugar Sweetened Soda

Experimental

24oz. soda per day

干预措施: Sugar Sweetened Soda (Dietary Supplement)

Reduced Fat Milk

Experimental

20 oz. reduced fat (2%) milk per day

干预措施: Reduced Fat Milk (Dietary Supplement)

结局指标

主要结局

LDL peak particle diameter

时间窗: 3 weeks

次要结局

  • Plasma triglycerides(3 weeks)
  • LDL-cholesterol(3 weeks)
  • HDL-cholesterol(3 weeks)
  • Blood pressure(3 weeks)
  • LDL subclass concentrations(3 weeks)
  • Apolipoprotein B(3 weeks)
  • Apolipoprotein AI(3 weeks)
  • Apolipoprotein CIII(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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