Lipid ProfileNCT04317638
Lipid Profile of Infants on Different Feeding Regimens
An observational study of Lipid Profile, run by Assiut University.
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.
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 group | Role | What they receive |
|---|---|---|
| breastfed group | Infants on exclusive breast feeding for the first 6 months of life and their mothers Receives: Other: Lipid profile | |
| formula fed group | Infants on exclusive formula feeding for the first 6 months of life Receives: Other: Lipid profile | |
| mixed fed group | Infants 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.
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
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.
- First posted23 Mar 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lipid ProfileStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Remon Riad Sedrak, Assiut University
- Investigators
- Nagla H Abu Faddan, PHD, Study chair, Assiut University Children HospitalAmir M Abo El-Gheit, PHD, Study chair, Assiut University Children Hospital
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 22624983Harit 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 17327867Owen 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Profile of Full-term Infants on Different Feeding Regimen: a Comparative Study
- ClinicalTrials.gov ID
- NCT04317638
- Acronym / sponsor ID
- Lipid profile of infants
- Conditions
- Lipid Profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breastfed group | – | Other: Lipid profileInfants on exclusive breast feeding for the first 6 months of life and their mothers |
| formula fed group | – | Other: Lipid profileInfants on exclusive formula feeding for the first 6 months of life |
| mixed fed group | – | Other: Lipid profileInfants on mixed feeding (formula \& breast feeding) and their mothers |
Who may qualify
- Ages
- 12 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants seeking medical advice in the outpatient clinics of Assiut University Children Hospital
Key inclusion criteria (1 listed)
- Apparently healthy infants during the first 6 months of life on different feeding regimen
Key exclusion criteria (17 listed)
- Infants with perinatal problems .e.g.,
- Infants born to mothers having any chronic disease e.g.,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid profile3 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. | Other | breastfed group, formula fed group, mixed fed group |
Primary outcome
comparison between lipid profiles of the infants of the 3 groups
Time frame: baseline
analysis of the results of lipid profiles of infants on different feeding regimens at the age of 14 weeks and 6 months
correlation of lipid profiles of infants and their mothers
Time frame: baseline
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 22624983Martin 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.
- Background: PubMed 17327867Harit 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.
- Background: PubMed 17093156Owen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagla H Abu Faddan, PHD study chair
Assiut University Children Hospital
Amir M Abo El-Gheit, PHD study chair
Assiut University Children Hospital
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.