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临床试验/NCT06250647
NCT06250647已完成不适用

Effect of Dietary Intervention With a High Intake of Vitamin K on Insulin, Osteocalcin, Leptin, Vitamin K Serum Levels and Cardiovascular Risk in Young Adults With and Without Overweight or Obesity.

University of Guadalajara2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年2月6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
72
试验地点
2
主要终点
vitamin K serum levels

研究概览

简要总结

The goal of this clinical trial is to compare the effect of a high vitamin K diet intervention on vitamin K, insulin, osteocalcin serum levels and the cardiovascular risk percentage in normal weight and overweight or obese young adults. The main questions it aims to answer are: • Does a diet intervention containing 500mcg of vitamin K increases serum vitamin K levels? • Are vitamin K serum levels after the 500mcg of vitamin K diet intervention associated with insulin and osteocalcin serum levels or the cardiovascular risk percentage in normal weight and overweight or obese young adults? Participants will have to follow a diet intervention that contains 500mcg of vitamin K, given as a cyclic menu for 6 weeks. Also, participants will have to assist weekly to nutritional monitoring and to report any situation they observed regarding the intervention during this study. Researchers will compare normal weight and overweight or obese groups with diet intervention with normal weight and overweight or obese groups without diet intervention and only dietetic recommendations to see if vitamin K serum levels, insulin, osteocalcin and the cardiovascular risk percentage improve after the 6 weeks diet intervention.

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
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • young adults
  • acceptation for participate
  • acceptation to asist to monitoring sessions
  • sign information consent

排除标准

  • under other dietetic intervention
  • under medications that interfere with vitamin K or diminish its absorbtion
  • vitamin E or A intake supplements
  • previous diagnose of metabolic syndrome, diabetes mellitus, hypertension, cancer or dyslipidemia.
  • chronic alcohol intake
  • some medical or health situation that impedes the following of the program

结局指标

主要结局

vitamin K serum levels

时间窗: basal and after 6 weeks of diet intervention

ng/mL

Cardiovascular Risk Percentage

时间窗: basal and after 6 weeks of diet intervention

percentage (%)

insulin serum levels

时间窗: basal and after 6 weeks of diet intervention

mcUI/L

次要结局

  • Osteocalcin(basal and after 6 weeks of diet intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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