Diastolic Blood Pressure and Lipid Profile in Infants (ERAhmed)

August 1, 2018 updated by: El-Shazly Rabeeh Ahmed, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be recruited outpatient clinic of Assiut pediatric hospital

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure
Time Frame: Around one year
Value of Infants feeding
Around one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum cholesterol level
Time Frame: Around one year
Value of breastfeeding
Around one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ERAhmed AssiutU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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