Energy Regulation and Nutritional Status of Children: A Satiation Study

University of Ghana41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Underweight Stunting Healthy

Interventions

High energy preloadBEHAVIORAL

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

Low energy preloadBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Ghana

Accra, Ghana

Outcomes

Primary Outcomes

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%

Time frame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal

Secondary Outcomes

Difference in total energy consumed

The total amount of energy consumed from preload plus test meal after high compared to low energy preload

Time frame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal

Data from ClinicalTrials.gov

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