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临床试验/NCT02266641
NCT02266641已完成不适用

Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2014年10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
118
试验地点
2
主要终点
Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the first trimester visit of pregnancy

研究概览

简要总结

Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome molecule, to promote the individual nutrient growth factor of growth and development. Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl metabolic nutrition environment. It not only leads to fetal growth mutation - such as folate and choline deficiency, increasing the risk of fetal neural tube defect but also induce abnormal modifying of fetuses's post-genomic methylation markers, may alter imprinted genes function of progenitors, recompile threshold sensitivity or domain in regulation of metabolic reactions of offspring, resulting in long-lasting effect, increasing the risk of chronic diseases of offspring such as cancer. According to the National Nutrition Survey results show that a considerable proportion of the Taiwanese people had poor one-carbon nutritional status. 48% of women intake 66% below the recommended intake reference value of folate. Whether inadequate parental one-carbon nutrients intake combined with genetic polymorphisms of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus, affecting fetal growth and modifying the risk of cancer development relationship of offspring. It is due to the lack of local ethnic data and empirical scientific reference at home and abroad, so it can not plan an effective maternal and children nutrient education and prevention strategies about methyl nutrition for early cancer prevention for Taiwanese. Therefore, indigenous people is the intended population of study in this project, screening of healthy pregnant women with high risk factor for cancer and obese pregnant women, and detection of one-carbon nutrient intake and biochemical assessment of the nutritional status of the study group. Supplying nutrition education intervention or multivitamin supplement to improve the poor nutritional status of persons. Using related DNA methylation imprint marker about offspring growth and modifying development of cancer as assessment, this project explores the appropriate one-carbon nutrient intake in parents and children and the assessments in regulation of growth and reducing the cancer-related risk.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy pregnant women aged 21-40 years with first and single fetal pregnancy
  • Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had diabetes
  • Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had cancer
  • Healthy pregnant women, who are overweight/obesity (pre-pregnancy BMI≧24 kg/m2) or her lineal relative with overweight/obesity, aged 21-40 years with first and single fetal pregnancy.

排除标准

  • Pregnant women who had heart disease, kidney disease, cancer or accepting medical treatment

研究组 & 干预措施

healthy pregnant women

Active Comparator

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

干预措施: nutrition counseling (Behavioral)

healthy pregnant women

Active Comparator

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

干预措施: multivitamin supplement (Dietary Supplement)

healthy pregnant women's lineal relative with cancer

Experimental

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

干预措施: multivitamin supplement (Dietary Supplement)

healthy pregnant women's lineal relative with cancer

Experimental

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

干预措施: nutrition counseling (Behavioral)

pregnant women or lineal relative with overweight/obesity

Experimental

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

干预措施: nutrition counseling (Behavioral)

pregnant women or lineal relative with overweight/obesity

Experimental

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

干预措施: multivitamin supplement (Dietary Supplement)

healthy pregnant women's lineal relative with diabetes

No Intervention

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

结局指标

主要结局

Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the first trimester visit of pregnancy

时间窗: 7-10 weeks

Using semiquantitative food frequency questionnaires (FFQ) to calculate dietary intake of one-carbon nutrient

Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the second trimester of pregnancy

时间窗: 20-28 weeks

Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient

Assessment of maternal one-carbon nutrient (folate, choline, betaine, Vitamine B12) intake at the third trimester of pregnancy

时间窗: 36-37 weeks

Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient

次要结局

  • Measure maternal blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)(24-28 weeks)
  • Measure maternal blood imprinted genes (sonic hedgehog, insulin-like growth factor 2, long interspersed nuclear element 1, etc.) DNA methylation status, DNA 8-Hydroxydeoxyguanosine (8-OHdG) and inflammatory markers (TNF-α, NF-κB, Interleukin, etc.)(37-40 weeks)
  • Measure maternal blood imprinted genes (sonic hedgehog, insulin-like growth factor 2, long interspersed nuclear element 1, etc.) DNA methylation status, DNA 8-Hydroxydeoxyguanosine and inflammatory markers (TNF-α, NF-κB, Interleukin, etc.)(24-28 weeks)
  • Measure maternal blood, cord blood and urine biochemistry (folate, choline, betaine, homocysteine, Vitamine B2, Vitamine B6, Vitamine B12, etc.)(37-40 weeks)
  • Measure maternal and cord blood and placenta tissues MTHFR C677T genotypes(37-40 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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