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

NCT ID: NCT02266641

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Off-spring Cancer Risk

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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healthy pregnant women

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

Group Type ACTIVE_COMPARATOR

nutrition counseling

Intervention Type BEHAVIORAL

Pregnancy diet (include one-carbon nutrients)

multivitamin supplement

Intervention Type DIETARY_SUPPLEMENT

healthy pregnant women's lineal relative with cancer

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

Group Type EXPERIMENTAL

nutrition counseling

Intervention Type BEHAVIORAL

Pregnancy diet (include one-carbon nutrients)

multivitamin supplement

Intervention Type DIETARY_SUPPLEMENT

pregnant women or lineal relative with overweight/obesity

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

Group Type EXPERIMENTAL

nutrition counseling

Intervention Type BEHAVIORAL

Pregnancy diet (include one-carbon nutrients)

multivitamin supplement

Intervention Type DIETARY_SUPPLEMENT

healthy pregnant women's lineal relative with diabetes

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nutrition counseling

Pregnancy diet (include one-carbon nutrients)

Intervention Type BEHAVIORAL

multivitamin supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chien-Nan Lee

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Kuang-Ta Huang

Role: PRINCIPAL_INVESTIGATOR

Hueishin women and children clinic

Chin-Pao Cheng

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Rwei-Fen S. Huang

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201401034RINB

Identifier Type: -

Identifier Source: org_study_id

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