Diastolic Blood Pressure and Lipid Profile in Infants

NCT ID: NCT03612427

Last Updated: 2018-08-02

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-12-01

Brief Summary

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The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD.

Detailed Description

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The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD, since they have faster early growth rate and higher risk of overweight, type 2 diabetes, high blood pressure, and unfavorable blood lipid profile in adult age. Formula-fed preterm infants have higher serum C-reactive protein (CRP) concentration, higher serum low-density lipoprotein to high-density lipoprotein (LDL:HDL) ratio, and higher serum apolipoprotein B to apolipoprotein A1 (apoB:apoA1) ratio in adolescence as compared with preterm infants receiving banked breast milk.

Conditions

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Breastfeeding, Exclusive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breastfed infants

Infants depending on breastfeeding S. Cholesterol S. Triglycerides S. HDL Cholesterol

S. Cholesterol S. Triglyceride

Intervention Type DIETARY_SUPPLEMENT

S. Cholesterol S. Triglycerides

Formula-fed infants

Infants have formula feeding S. Cholesterol S. Triglycerides S. HDL Cholesterol

S. Cholesterol S. Triglyceride

Intervention Type DIETARY_SUPPLEMENT

S. Cholesterol S. Triglycerides

Interventions

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S. Cholesterol S. Triglyceride

S. Cholesterol S. Triglycerides

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Blood pressure

Eligibility Criteria

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Inclusion Criteria

1. Breastfed infants
2. Formula-fed infants
3. Raw milk fed infants
4. Mixed fed infants

1. Breast milk plus raw milk
2. Breast milk plus formula

Exclusion Criteria

1\. Children with Cong. Heart Disease, family history of congenital hyperlipidemia and cases which prove hyperlipidemia of high levels (congenital).
Minimum Eligible Age

10 Months

Maximum Eligible Age

14 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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El-Shazly Rabeeh Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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El-Shazly Ahmed, MBBCh

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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El-Shazly Ahmed, MBBCh

Role: CONTACT

01000690960

Other Identifiers

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ERAhmed AssiutU

Identifier Type: -

Identifier Source: org_study_id

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