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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03900663
Other study ID # Delivery,feeding,child obesity
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2019
Est. completion date October 2021

Study information

Verified date April 2019
Source Assiut University
Contact Maher M. Ahmed, Professor
Phone 01066006605
Email maher.farghali@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- Feeding and growth during infancy have been associated with later life body mass index.

- Breastfeeding seems to have a small but consistent protective effect against obesity in children.

- The Cholesterol content of human milk is 6-fold greater than that of the standard infant formulas.

- Infants delivered by caesarean section may be at increased risk of childhood obesity and adulthood obesity.


Description:

- Previous guidelines recommended that infants who are exclusively breast fed for the first 6 months of life, with particular solid foods gradually introduced from 6 months associated with lower childhood fat mass.

- The stated reason for discouraging introduction of solids to infant before 4 months include the risk of excessive weight gain, vulnerability of the gut to infection and increased susceptibility to the development of allergic disease.

- Infants whose dietary pattern was most similar to feeding guidelines, with high frequencies of fresh fruit and vegetables, home prepared foods and breast milk, gained weight and skin fold thickness more rapidly from 6 to12 months than other infants, independent of milk feeding, age of introduction of solids and maternal factors.

- Exclusively breastfed infants had significantly higher Total Cholesterol (TC) level and Low density Lipoprotein level (LDL) and lower High density lipoprotein level (HDL) as compared to mixed-fed infants in the first 6 months of life.

- Exclusive breast feeding seems to have a protective effect against some risk factors for cardiovascular disease in later life, as those who exclusively breastfed had lower level of plasma low density lipoprotein (LDL) cholesterol conc., higher level of high density lipoprotein (HDL) and lower LDL/HDL ratio than those bottle fed.

- Early weaning is related to rapid weight gain in infancy, and this may have implication for childhood obesity.

- Vaginally delivered children are colonised with bacterial strains from the mothers' vagina during delivery in contrast to children delivered by CS, and these differences seem to persist throughout infancy.

- The gut microbiota may have a role in energy harvesting, hence inoculation with maternal microbiota through vaginal delivery may be protective for childhood overweight compared with delivery by CS.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 3 Years
Eligibility Inclusion Criteria:

- Infants of both sexes

- Infants from 2 to 3 years

- Breast fed or formula fed or mixed fed infants

Exclusion Criteria:

- Children less than 2 and more than 3 years ago.

- Children having family history of chronic illness

- Children having family history of metabolic

- Children fed cow milk or buffalo milk.

- Infants delivered preterm.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Anthropometric measures
Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Goldani HA, Bettiol H, Barbieri MA, Silva AA, Agranonik M, Morais MB, Goldani MZ. Cesarean delivery is associated with an increased risk of obesity in adulthood in a Brazilian birth cohort study. Am J Clin Nutr. 2011 Jun;93(6):1344-7. doi: 10.3945/ajcn.110.010033. Epub 2011 Apr 20. — View Citation

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. Epub 2007 Feb 28. — View Citation

Ravelli AC, van der Meulen JH, Osmond C, Barker DJ, Bleker OP. Infant feeding and adult glucose tolerance, lipid profile, blood pressure, and obesity. Arch Dis Child. 2000 Mar;82(3):248-52. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Obesity Body mass index (BMI) kg/m2 Through one year
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