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临床试验/NCT00842543
NCT00842543已完成不适用

Effects Of A Fruit And Vegetable Juice Concentrate (FVJC) In-Vivo On Retinol Binding Protein 4 And Antioxidant Capacity In Normal And Overweight Boys -A Pilot Randomized Placebo Controlled Study

Nemours Children's Clinic2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2008年7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
39
试验地点
2
主要终点
Beta-carotene Levels Between Overweight and Lean Boys at Baseline

研究概览

简要总结

Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. The boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. Careful anthropometric measures and body composition by DEXA will be performed. Nutritional and exercise counseling will be given at the start of the study. The outcome measures will include differences in serum RBP4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of FVJC in a randomized double blind placebo control manner.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • 6-10 year old healthy boys
  • Lean or overweight
  • Have not started puberty

排除标准

  • Chronic illness, asthma, or GI disorder
  • Vegan Diet
  • Use of routine medications or vitamins 4 weeks before study

结局指标

主要结局

Beta-carotene Levels Between Overweight and Lean Boys at Baseline

时间窗: Baseline

Value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.

Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys

时间窗: Baseline and 6 months

Value at 6 months minus value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Atilio Canas, MD

Principal Investigator

Nemours Children's Clinic

研究点 (2)

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