Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators

The research plan is divided into two parts. The first part is the correlation study .It is planned to include women who prepare for pregnancy or in the early stages of pregnancy to carry out the detection of 25 loci SNP of 21 genes of 9 nutrients, to predict the nutritional abnormalities of 9 nutrients, and to determine the nutritional status of 9 nutrients, and then verify the correlation between nutrient metabolism related gene SNP and nutrient nutrition status .The second part selects iron and selenium which are commonly lacking in Chinese women of childbearing age. A intervention study is designed for these two nutrients. According to the SNP grouping of related gene loci, observe the effect of nutrition intervention and explore the nutrition intervention strategies of different SNP individuals.

Study Overview

• Status: Unknown
• Conditions: Pregnant Women
• Intervention / Treatment: Dietary supplement: Normal iron; Dietary supplement: Weak iron; Dietary supplement: Normal selenium; Dietary supplement: Weak selenium

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• preparing for pregnancy or early pregnancy women (< 12w)
• no major surgery, trauma, or important viscera disease
• no long-term medication history
• No serious mental and psychological behavior abnormalities
• resident in Beijing, can accept regular prenatal in Beijing area
• signed informed consent

Exclusion Criteria:

• have taken medications that may affect the metabolism of nutrients, but are unable to provide their ingredients or doses, making it difficult to judge their effects
• From the first three months of this pregnancy to the time of inclusion, taking drugs that interfere with the absorption, metabolism, and utilization of nutrients.
• From the first three months of this pregnancy to the time of inclusion, Pregnant woman took iron, selenium, vitamin B6, vitamin B12, vitamin D preparations, and the dosage was higher than the corresponding physiological standard.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normal iron	Dietary supplement: Normal iron; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.; Dietary supplement: Weak iron; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
EXPERIMENTAL: Weak iron	Dietary supplement: Normal iron; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.; Dietary supplement: Weak iron; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
EXPERIMENTAL: Normal selenium	Dietary supplement: Normal selenium; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.; Dietary supplement: Weak selenium; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
EXPERIMENTAL: Weak selenium	Dietary supplement: Normal selenium; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.; Dietary supplement: Weak selenium; The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the results of nutritional evaluation of selenium-related genes and selenium levels in vivo	The correlation between the nutrition evaluation results of selenium gene monitoring and the levels of selenium in vivo	lasted for 4 weeks
Correlation between the results of nutritional evaluation of iron-related genes and iron levels in vivo	The correlation between the nutrition evaluation results of iron gene monitoring and the levels of iron in vivo	lasted for 4 weeks
Correlation between the results of nutritional evaluation of vitamin B6-related genes and vitamin B6 levels in vivo	The correlation between the nutrition evaluation results of vitamin B6 gene monitoring and the levels of vitamin B6 in vivo	lasted for 4 weeks
Correlation between the results of nutritional evaluation of vitamin B12-related genes and vitamin B12 levels in vivo	The correlation between the nutrition evaluation results of vitamin B12 gene monitoring and the levels of vitamin B12 in vivo	lasted for 4 weeks
Correlation between the results of nutritional evaluation of vitamin D-related genes and vitamin D levels in vivo	The correlation between the nutrition evaluation results of vitamin D gene monitoring and the levels of vitamin D in vivo	lasted for 4 weeks
Correlation between the results of nutritional evaluation of pantothenic acid-related genes and pantothenic acid levels in vivo	The correlation between the nutrition evaluation results of pantothenic acid gene monitoring and the levels of pantothenic acid in vivo	lasted for 4 weeks
Correlation between gestational diabetes-related gene monitoring results and glycosylated hemoglobin，fasting blood glucose, fasting insulin levels in vivo	The correlation between the nutrition evaluation results of gestational diabetes-related gene monitoring and the levels of glycosylated hemoglobin，fasting blood glucose, fasting insulin in vivo	lasted for 4 weeks
Correlation between gestational hypertension-related gene monitoring results and homocysteine, serum folic acid and RBC Folate levels in vivo	TThe correlation between the nutrition evaluation results of gestational hypertension-related gene monitoring and the levels of homocysteine, serum folic acid and RBC Folate in vivo	lasted for 4 weeks
Correlation between hyperlipidemia-related gene monitoring results and the level of plasma lipid in vivo.	The correlation between the nutrition evaluation results of hyperlipidemia-related gene monitoring and the levels of plasma lipid in vivo	lasted for 4 weeks
nutritional status	The nutritional status of selenium was compared between the normal selenium and week selenium group; The nutritional status of iron was compared between the normal iron and the weak group. Meanwhile, compare the selenium and iron nutritional status of the four groups before and after the intervention.	lasted for 4 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Zhao R, An Z, Sun Y, Xia L, Qiu L, Yao A, Liu Y, Liu L. Metabolic profiling in early pregnancy and associated factors of folate supplementation: A cross-sectional study. Clin Nutr. 2021 Sep;40(9):5053-5061. doi: 10.1016/j.clnu.2021.01.012. Epub 2021 Jan 23.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): September 10, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (ACTUAL): August 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Iron; Selenium
• Other Study ID Numbers: hs-1646

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No