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

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National Taiwan University

Status

Completed

Conditions

Off-spring Cancer Risk

Treatments

Behavioral: nutrition counseling
Dietary Supplement: multivitamin supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT02266641
201401034RINB

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Healthy pregnant women aged 21-40 years with first and single fetal pregnancy
  2. Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had diabetes
  3. Healthy pregnant women aged 21-40 years with first and single fetal pregnancy and lineal relative had cancer
  4. 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.

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

118 participants in 4 patient groups

healthy pregnant women
Active Comparator group
Description:
Supply nutrition counseling and multivitamin supplement to people with poor nutritional status
Treatment:
Dietary Supplement: multivitamin supplement
Behavioral: nutrition counseling
healthy pregnant women's lineal relative with cancer
Experimental group
Description:
Supply nutrition counseling and multivitamin supplement to people with poor nutritional status
Treatment:
Dietary Supplement: multivitamin supplement
Behavioral: nutrition counseling
pregnant women or lineal relative with overweight/obesity
Experimental group
Description:
Supply nutrition counseling and multivitamin supplement to people with poor nutritional status
Treatment:
Dietary Supplement: multivitamin supplement
Behavioral: nutrition counseling
healthy pregnant women's lineal relative with diabetes
No Intervention group
Description:
Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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