Diastolic Blood Pressure and Lipid Profile in Infants

Breastfeeding, Exclusive Clinical Trial

— ERAhmed  

Official title:

Diastolic Blood Pressure and Lipid Profile in Breastfed Vs. Formula Fed Infants ( As Early Indicators for Cardiovascular Disease ).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03612427
• Other study ID #: ERAhmed AssiutU
• Status: Not yet recruiting
• Start date: August 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: El-Shazly Ahmed, MBBCh
• Phone: 01000690960
• Email: Shazliahmed777[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 14 Months

Eligibility

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).

Related Conditions & MeSH terms

• Breastfeeding, Exclusive

Intervention

Dietary Supplement:
• S. Cholesterol S. Triglyceride
S. Cholesterol S. Triglycerides

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic blood pressure	Value of Infants feeding	Around one year
Secondary	Serum cholesterol level	Value of breastfeeding	Around one year