Clinical trial NCT05346549: Energy Regulation and Nutritional Status of Children: A Satiation Study
Official title: Energy Regulation and Nutritional Status of Children: A Satiation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underweight
Stunting
Healthy
Lead sponsor: University of Ghana
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: University of Stirling
First posted: 2022-04-26
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: cross-over energy compensation study, participants acting as their own controls
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compensation index (Compx)
timeFrame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
Secondary outcomes:
measure: Difference in total energy consumed
timeFrame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
affiliation: University of Ghana
name: Eunice Nortey
role: PRINCIPAL_INVESTIGATOR
References: