Diastolic Blood Pressure and Lipid Profile in Infants

• Conditions: Breastfeeding, Exclusive
• Interventions: Dietary Supplement: S. Cholesterol S. Triglyceride

• Registration Number: NCT03612427
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-19
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breastfed infants	S. Cholesterol S. Triglyceride	Infants depending on breastfeeding S. Cholesterol S. Triglycerides S. HDL Cholesterol
Formula-fed infants	S. Cholesterol S. Triglyceride	Infants have formula feeding S. Cholesterol S. Triglycerides S. HDL Cholesterol

Primary Outcome Measures

Name	Time	Method
Diastolic blood pressure	Around one year	Value of Infants feeding

Secondary Outcome Measures

Name	Time	Method
Serum cholesterol level	Around one year	Value of breastfeeding