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Lipid ProfileNCT04317638

Lipid Profile of Infants on Different Feeding Regimens

An observational study of Lipid Profile, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lipid profile of full-term infants on different regimens. The aim of the study is to compare infant's lipid profiles on different feeding regimen during the first 6 months of life and its correlation with their mothers' lipid profiles (exclusive breastfeeding and mixed feeding) and to compare infants' lipid profiles… Read more about this study

Who is it for?
Ages 12 weeks to 6 monthsHealthy volunteers can take part
Conditions the study is for
Lipid Profile
What is being tested?
Lipid profile
How many people
300 participants
Where
No sites listed yet
Study dates
Jan 2021to Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 weeks to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Infants seeking medical advice in the outpatient clinics of Assiut University Children Hospital

Who may be able to join

  • Apparently healthy infants during the first 6 months of life on different feeding regimen

Who cannot join

  • Infants with perinatal problems .e.g.,
  • birth asphyxia
  • premature rupture of membranes
  • hypoglycemia
  • hypothermia
  • meconium stained amniotic fluid
Show all 17Show fewer
  • pathological jaundice
  • congenital malformations
  • clinical evidence of chromosomal abnormalities
  • Infants born to mothers having any chronic disease e.g.,
  • diabetes mellitus
  • gestational diabetes
  • hypertension
  • pre-eclampsia
  • eclampsia
  • hypo/hyperthyroidism
  • on any long-term medication

Trial locations and contacts

No sites are listed yet.

Maria Remon Riad, M.B.B.CH contact

+201019239937

maria.r.riad@gmail.com

About this study

Official title: Lipid Profile of Full-term Infants on Different Feeding Regimen: a Comparative Study

Lipid profile of full-term infants on different regimens. The aim of the study is to compare infant's lipid profiles on different feeding regimen during the first 6 months of life and its correlation with their mothers' lipid profiles (exclusive breastfeeding and mixed feeding) and to compare infants' lipid profiles on different feeding regimen with each other (including those on exclusive formula feeding).

Read the detailed description

Infant and young child feeding is critical for their health and survival. Based on well-established evidence, the World Health Organization (WHO) and the United Nations Children's fund (UNICEF) recommend that mothers put newborns to the breast within one hour of birth, breastfeed infants exclusively for the first six months and continue to breastfeed for two years and beyond, together with nutritionally adequate, safe, age-appropriate, responsive feeding of solid, semi-solid and soft food starting in the sixth month.

For the first six months of life, breast milk alone is the ideal nourishment, providing all of the nutrients including minerals and fat soluble vitamins, an infant needs, meaning that no other liquid or food is needed.

In addition to providing a generally adequate nutrient supply that support normal growth and development , breastfeeding has been linked to multiple other advantages including a reduced risk of infection and long-term benefits for the risk of obesity, type II diabetes mellitus, blood pressure and better performance in intelligence tests.

The macro-nutrient composition of human milk varies within mothers according to nutritional status and across lactation. The mean macro-nutrient composition of mature, term milk is estimated to be approximately 0.9 to 1.2 gm/dl for proteins, 3.2 to 3.6 gm/dl for fats and 6.7 to 7.8 gm/dl for lactose.

There have been several systematic reviews supporting the positive effects of breastfeeding on cardiovascular risk factors, such as obesity and type 2 diabetes (DMII), hypertension. Breastfeeding also reduces plasma levels of total cholesterol (TC) and low density lipoprotein (LDL).

Breast milk is a protective factor against obesity. This effect could be explained by existing differences in macro-nutrients. Moreover, there are physiological differences between breast milk and artificial formulas in terms of their nutrients and hormone contents. For instance, protein content of baby formulas is higher than that of breast milk, and leptin exists in breast milk, but not in artificial formulas. Due to their high fat and protein contents, baby formulas would lead to increased secretion of Insulin Growth Factor-type 1 (IGF-1),and subsequently to stimulation of adipocytes, which eventually result in excess weight. Moreover, breastfeeding affects the intake of calorie and protein, insulin secretion, balancing fat reserves, and adipocyte size. The effect of breastfeeding is found to be independent from dietary patterns and physical activity in adulthood.

Many studies have confirmed the protective role of breastfeeding against type II diabetes mellitus. This effect is considered to be because of the difference in composition of breast milk and the difference in hormones of insulin, motilin, introglucagon, neurotencin, and pancreatic polypeptide in breast milk and artificial formulas, which in turn would lead to lower subcutaneous fat deposition in breastfed infants.

The effect of breastfeeding on hypertension has attracted much interest because of the differences between breast milk and artificial formulas, mainly in terms of their content of sodium and fatty acids. It is documented that breastfeeding can affect systolic and diastolic blood pressures in adulthood. The effect of breastfeeding on blood pressure in adulthood can be partly explained through the following mechanisms: (1) reduced sodium intake in infancy, (2) high content of long-chain unsaturated fatty acids in breast milk, which is an important component of the tissue membrane system, as coronary endothelial system, (3) protection against hyperinsulinemia in infancy, as well as prevention of insulin resistance in early life, adolescence, and adulthood.

There is a relationship between the molecular composition (especially lipids, glycerides and sterols) of the maternal plasma, milk and her infant.

There is paucity of studies comparing lipid profiles of exclusively breastfed and mixed fed infants and those correlating lipid profiles of breastfed infants and their mothers' lipid profiles.

Conditions
Lipid Profile
Being tested
Lipid profile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lipid profileOther

    3 ml of venous blood from the breastfed and infants and mothers of the breastfed and mixed fed infants will be taken under aseptic precautions for determination of triglycerides (TG), cholesterol, high density lipoprotein (HDL), very low density lipoprotein (LDL) at the age of 14 ± 2 weeks and the age of 6 months.

Study groups in NCT04317638
Study groupRoleWhat they receive
breastfed groupInfants on exclusive breast feeding for the first 6 months of life and their mothers
Receives: Other: Lipid profile
formula fed groupInfants on exclusive formula feeding for the first 6 months of life
Receives: Other: Lipid profile
mixed fed groupInfants on mixed feeding (formula \& breast feeding) and their mothers
Receives: Other: Lipid profile

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparison between lipid profiles of the infants of the 3 groups

    analysis of the results of lipid profiles of infants on different feeding regimens at the age of 14 weeks and 6 months

    Measured: baseline

  2. correlation of lipid profiles of infants and their mothers

    analysis of the results of lipid profiles of infants on exclusive breast feeding and mixed feeding (breast and formula feeding) and the results of lipid profiles of their mothers

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study startJan 2021 (estimated)
  3. Primary completionJan 2022 (estimated)
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317638
Sponsor's protocol ID
Lipid profile of infants
Status last verified
Mar 2020
First submitted
19 Mar 2020
Last updated
24 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Martin MA, Lassek WD, Gaulin SJ, Evans RW, Woo JG, Geraghty SR, Davidson BS, Morrow AL, Kaplan HS, Gurven MD. Fatty acid composition in the mature milk of Bolivian forager-horticulturalists: controlled comparisons with a US sample. Matern Child Nutr. 2012 Jul;8(3):404-18. doi: 10.1111/j.1740-8709.2012.00412.x. Epub 2012 May 24.

    PubMed 22624983
  • Harit D, Faridi MM, Aggarwal A, Sharma SB. Lipid profile of term infants on exclusive breastfeeding and mixed feeding: a comparative study. Eur J Clin Nutr. 2008 Feb;62(2):203-9. doi: 10.1038/sj.ejcn.1602692. Epub 2007 Feb 28.

    PubMed 17327867
  • Owen CG, Martin RM, Whincup PH, Smith GD, Cook DG. Does breastfeeding influence risk of type 2 diabetes in later life? A quantitative analysis of published evidence. Am J Clin Nutr. 2006 Nov;84(5):1043-54. doi: 10.1093/ajcn/84.5.1043.

    PubMed 17093156

Questions about this trial

What is this clinical trial studying?

An observational study of Lipid Profile, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Remon Riad, M.B.B.CH (+201019239937, maria.r.riad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison between lipid profiles of the infants of the 3 groups (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317638, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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