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ERAhmed: Diastolic Blood Pressure and Lipid Profile in Infants

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03612427
Collaborator
(none)
120
Enrollment
16
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: S. Cholesterol S. Triglyceride

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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Diastolic Blood Pressure and Lipid Profile in Breastfed Vs. Formula Fed Infants ( As Early Indicators for Cardiovascular Disease ).
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Breastfed infants

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

Dietary Supplement: S. Cholesterol S. Triglyceride
S. Cholesterol S. Triglycerides
Other Names:
  • Blood pressure

    		•
    Formula-fed infants

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

    Dietary Supplement: S. Cholesterol S. Triglyceride
    S. Cholesterol S. Triglycerides
    Other Names:
  • Blood pressure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diastolic blood pressure [Around one year]

      Value of Infants feeding

    Secondary Outcome Measures

    1. Serum cholesterol level [Around one year]

      Value of breastfeeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Months to 14 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Breastfed infants

    2. Formula-fed infants

    3. Raw milk fed infants

    4. Mixed fed infants

    5. Breast milk plus raw milk

    6. 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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: El-Shazly Ahmed, MBBCh, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    El-Shazly Rabeeh Ahmed, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03612427
    Other Study ID Numbers:
    • ERAhmed AssiutU
    First Posted:
    Aug 2, 2018
    Last Update Posted:
    Aug 2, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 2, 2018