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临床试验/NCT00872365
NCT00872365已完成不适用

Effect of Micronutrients and Exercise During Pregnancy on Factors Related With Non-Transmissible Chronic Diseases

Universidad del Valle, Colombia1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
320
试验地点
1
主要终点
Endothelium-dependent flow mediated dilation

研究概览

简要总结

At the moment, most of efforts to prevent non-transmissible chronic diseases at population level have been centered in promoting healthful behaviors like physical activity, consumption of fruits and vegetables, and discouraging from the consumption of tobacco and alcohol in adult population, but the results have been little hopeful. In the last years, manifold studies have indicated the relation between metabolic alterations and of the fetal growth with the development of non-transmissible chronic diseases in adult age. More recently, it has been proposed that maternal factors (endothelial function, oxidative stress and alterations in adipokines) and placental ones (mitochondrial dysfunction) are the precursory mechanisms of fetal metabolic alterations and of the later development of non-transmissible chronic diseases. Also, it has been suggested that possibly supplementation with micronutrients and the physical exercise during the gestation can regulate these maternal and placental factors. For the reasons just mentioned, it is necessary to clarify if these proposed factors are related to fetal metabolic alterations and if the supplementation during the gestation with micronutrients and/or the physical exercise can regulate them, which would be an early and novel alternative to fortify the prevention of non-transmissible chronic diseases in the population.

Purpose

  1. To evaluate the effect of associated both the maternal and placental metabolic factors to non-transmissible chronic diseases in newborn.
  2. To evaluate the effect of the physical exercise and the complementation with micronutrients during the pregnancy either in the endothelial function, the levels of adipokines, the oxidative stress of the mother and the newborn, as in the placental mitochondrial function and the anthropometry of newborn.

详细描述

Hypothesis

  1. There is correlation between the metabolic factors, related to non-transmissible chronic diseases, of the mother and those of the newborn one.
  2. Supplementation with either micronutrients or physical exercise influence beneficially as much in the endothelial function, oxidative stress, the levels in adipokines of the mother and the newborn one like in the placental mitochondrial function.
  3. The simultaneous intervention with micronutrients or physical exercise produces an additional beneficial effect in the metabolic state of the mother and the newborn one.
  4. The metabolic alterations when being born are not exclusive of newborn with anthropometric measures located either in the inferior or superior percentiles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
  • •Live fetus at the routine ultrasound scan and a normal pregnancy.
  • •Gestational age 16 to 20 weeks
  • •Written informed consent will be obtained from each woman prior to the inclusion in the study.

排除标准

  • •History of high blood pressure
  • •Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
  • •Persistent bleeding after week 12 of gestation
  • •Poorly controlled thyroid disease
  • •Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
  • •History of miscarriage in the last twelve months
  • •Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).

研究组 & 干预措施

3

Other

Regular aerobic exercise + micronutrients

干预措施: Regular aerobic physical exercise (Behavioral)

3

Other

Regular aerobic exercise + micronutrients

干预措施: Micronutrients (Dietary Supplement)

1

Other

Regular aerobic physical exercise + placebo

干预措施: Regular aerobic physical exercise (Behavioral)

2

Other

Activities of daily living + Micronutrients

干预措施: Micronutrients (Dietary Supplement)

4

Placebo Comparator

Activities of daily living + placebo

干预措施: Activities of daily living + placebo (Other)

结局指标

主要结局

Endothelium-dependent flow mediated dilation

时间窗: Baseline / week 32-36 of gestation

次要结局

  • Biomarkers of endothelial function in blood from umbilical vein and maternal blood(Baseline / 32-36 weeks gestation and delivery)
  • Markers of mitochondrial function(Baseline / 32-36 weeks gestation and delivery)
  • Neonatal and maternal anthropometric indicators(Baseline / 32-36 weeks gestation and delivery)
  • Quality of life SF-12(Baseline / 32-36 weeks gestation and delivery)
  • Functional capacity (VO2max)(Baseline / 32-36 weeks gestation and delivery)

研究者

发起方
Universidad del Valle, Colombia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robinsón Ramírez

principal investigator

Universidad del Valle, Colombia

研究点 (1)

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