Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140696
Other study ID # PR-16094
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2017
Est. completion date August 30, 2019

Study information

Verified date January 2021
Source International Centre for Diarrhoeal Disease Research, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This formative research seeks to explore the use of egg (as a potential source of protein) as nutritional supplement for young children aged 6-8 months of either sex and breast milk composition of mothers of infants under 6 months old living in an urban slum of Dhaka city, Bangladesh.


Description:

Inadequate dietary protein intake and prolonged undernourishment can lead to short term and long-term consequences, which can deplete financial, physical, and social capital, further exacerbating the cycle of undernutrition. Subsequently, undernutrition contributes to the difficulty in achieving sustainable development and alleviating people from poverty. Children are a particular focus of interest because of the formative impact that nutrition can have on development. This is particularly relevant for the 159 million children from low and middle-income countries (LMICs) who are already stunted and many more are at risk of stunting. Understanding how to prevent child undernutrition is imperative to the future development of these children from LMICs. There is no study done so far to understand the quantity, preference and quality of egg protein intake in young children living in LMICs with high burden of undernutrition. In this context, eggs can serve as a potential source of protein to meet the unmet need of protein especially children living in resource-poor environments. Eggs contain high concentrations of choline - an important precursor of phospholipids, which can prevent adverse pregnancy outcomes, neural tube defects, changes in brain structure and function in offspring, and impaired language development during early childhood. Evidence is limited on the support of egg-related interventions for better nutrition outcomes in children from developing countries. Also there is very little evidence on the association between mother's breast milk composition with child's nutritional status.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months to 8 Months
Eligibility Inclusion Criteria: (i) consuming complementary food (liquid or semi-solid or solid food) other than breast milk at least once daily; (ii) free from any acute or chronic illness (es); (iii) no known case of congenital abnormality or chromosomal disorder, and (iii) no history of micro-nutrient or food supplementation in last two weeks prior to enrollment (iv) should be breastfed but not exclusively breastfed Exclusion Criteria: - Children whose parents/caregivers refuse to provide informed consent will not be enrolled

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Egg Alone
A chicken egg will be offered for 2 days
Egg and ready to use supplementary food (RUSF)
A chicken egg and ready to use supplementary food (RUSF) will be offered for 2 days
Egg and breast milk
A chicken egg and breast milk will be offered for 2 days

Locations

Country Name City State
Bangladesh icddr,b Mirpur Field site Dhaka

Sponsors (1)

Lead Sponsor Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ideal mode of feeding egg to young infants 6-8 months of age Each of the diets (egg alone or egg + RUSF or egg + breast milk) will be offered for 2 days each. The order of diets will be randomly allocated over a period of 6 days.On the first day, the child will be acclimatized with the given regime, and on second day, the mother will be asked to rate the offered food by using a 7-point Hedonic Scale in terms of colour, flavour, appearance and overall liking. A fixed amount of food will be offered. The food offered would be weighed before consumption and the left over will also be weighed to measure the actual amount of food consumed by the children. Total amount of offered food taken by the children will also be recorded. During the feeding time, field research assistants will observe the feeding session by using a structured tool. This combined approach (Hedonic scale and amount of food taken) will be used to determine the ideal mode of feeding of an egg by young infants. 2 days
See also
  Status Clinical Trial Phase
Completed NCT05502445 - The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People N/A
Completed NCT02001636 - Effect of Protein Supplementation After Bariatric Surgery N/A
Active, not recruiting NCT04565314 - ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth N/A
Completed NCT04791774 - Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness N/A
Completed NCT01041456 - Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass N/A
Recruiting NCT06403137 - Plant Protein Blend and Milk Protein Supplements in Older Individuals N/A
Completed NCT04587076 - Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery
Not yet recruiting NCT06458387 - Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery N/A
Completed NCT03181178 - Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants N/A
Completed NCT01040533 - Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass N/A
Not yet recruiting NCT05647135 - ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts
Recruiting NCT03947710 - Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices N/A
Completed NCT03032237 - Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods N/A