Healthy Clinical Trial
Official title:
Energy Regulation and Nutritional Status of Children: A Satiation Study
Verified date | January 2024 |
Source | University of Ghana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is study among children attending child welfare clinics in Greater Accra Region of Ghana. The investigators want to find out if moderately malnourished children regulate the food energy intake similarly to healthy children, using an established method to assess energy compensation.
Status | Completed |
Enrollment | 41 |
Est. completion date | October 30, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 36 Months |
Eligibility | Inclusion Criteria: - moderately malnourished (WHZ between -3 and -2 Z-scores) or stunted (HAZ<-2SD) or Healthy (WHZ >-2SD and HAZ >-2SD) children age 12-36 months. - Children should be attending child welfare clinics at the selected communities. - The children should be accompanied by a main caregiver who is actively involved in cooking for and/or feeding the child. - Children who are able to fast for at least 2 hours prior to the experiment. Exclusion Criteria: - Children with congenital disorders, disabilities and diseases requiring specialised care and hospitalisation. - Children with severe malnutrition with complications that required inpatient care. - Tube-fed children. - Children who are both stunted and moderately malnourished |
Country | Name | City | State |
---|---|---|---|
Ghana | University of Ghana | Accra |
Lead Sponsor | Collaborator |
---|---|
University of Ghana | University of Glasgow, University of Stirling |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compensation index (Compx) | The difference in energy consumed after high compared to low energy preload as percent of energy in preload. This will be calculated using a mathematical formulae:
Compx = [ (energy from meal following low energy preload - energy from meal after high energy preload) / (energy from high energy preload - energy from low energy preload) ] x 100% |
calculated on second visit (1-4 weeks after first visit) after consumption of second test meal | |
Secondary | Difference in total energy consumed | The total amount of energy consumed from preload plus test meal after high compared to low energy preload | calculated on second visit (1-4 weeks after first visit) after consumption of second test meal |
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