Energy Regulation and Nutritional Status of Children: A Satiation Study

Healthy Clinical Trial

Official title:

Energy Regulation and Nutritional Status of Children: A Satiation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346549
• Other study ID #: GHS-ERC:022/11/21
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: University of Ghana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Malnutrition originates from a complex interplay between genes and environment, manifesting in changes to hormones, metabolism, and behaviour. Energy regulation which determines food intake or avoidance plays a significant role in the cause, prevention and treatment of malnutrition. There is however limited knowledge of how energy regulation develops in children and its effect on their nutritional status in the context of undernutrition in children. A good understanding of energy regulation in children is therefore essential in designing interventions for tackling infant malnutrition.

A standardised energy compensation study will be undertaken in 60 children- 20 moderately malnourished, 20 stunted and 20 healthy. At two visits at least a week apart, the children will be given one of two similar tasting drinks in random order, one with very few calories and another with extra, without them knowing which is which. After 30 minutes they will eat as much as they want of a standardized lunch. All foods and drinks offered will be weighed before and after, to calculate the amount of energy eaten in total after the low energy drink, compared to the high energy drink.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy
• Stunting
• Thinness
• Underweight

Intervention

Behavioral:
• High energy preload
Tests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.
• Low energy preload
Tests the amount participants eat at a meal following ingestion of a low energy preload drink

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra

Sponsors (3)

Lead Sponsor	Collaborator
University of Ghana	University of Glasgow, University of Stirling

Country where clinical trial is conducted

Ghana, 

Outcome

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