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Energy Regulation and Nutritional Status of Children: A Satiation Study

Energy Regulation and Nutritional Status of Children: A Satiation Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05346549
Enrollment
41
Registered
2022-04-26
Start date
2022-05-02
Completion date
2023-10-30
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Stunting, Underweight

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.

Interventions

Tests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.

Tests the amount participants eat at a meal following ingestion of a low energy preload drink

Sponsors

University of Glasgow
CollaboratorOTHER
University of Stirling
CollaboratorOTHER
University of Ghana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Two similar tasting drinks will be used in random order, one low and one high energy after a standardized meal. The weight of food consumed will be measured by an observer blind to which supplement has been used.

Intervention model description

cross-over energy compensation study, participants acting as their own controls

Eligibility

Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Compensation index (Compx)calculated on second visit (1-4 weeks after first visit) after consumption of second test mealThe 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%

Secondary

MeasureTime frameDescription
Difference in total energy consumedcalculated on second visit (1-4 weeks after first visit) after consumption of second test mealThe total amount of energy consumed from preload plus test meal after high compared to low energy preload

Countries

Ghana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026