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.
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
- 是
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)
