Energy Regulation and Nutritional Status of Children: A Satiation Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Stunting; Underweight
• Intervention / Treatment: Behavioral: Low energy preload; Behavioral: High energy preload

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • University of Ghana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High energy; Child will be given a high energy drink: sugar free ribena squash (2kcal/100ml) plus a weighed amount of super soluble maxijul. Super Soluble Maxijul is a powdered carbohydrate energy source, which can be mixed with sweet or savoury foods/ liquids. It is safe for use in both children and adults that require fortification with a high or readily available carbohydrate. It is flavourless and tasteless offering little to no change in taste, flavor and texture of food being added to. It supplies 380 kcal energy per 100g powder. The amount given will supply 10% of the child's daily energy requirements per Kg - for example a 3-year old child weighing about 16 kg requires approximately 1300 kcal/day. Hence the high energy drink will supply the child with 130kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat standardized weighed buffet lunch of known energy content suitable for their age, chosen in consultation with the parents.	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.; Other Names: Satiation study
Experimental: Low energy; Child will be given a low energy drink of the same volume selected to be as similar as possible to the high energy drink: sugar free ribena squash containing 2kcal per 100ml. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing the same range of weighed buffet foods as above.	Behavioral: Low energy preload; Tests the amount participants eat at a meal following ingestion of a low energy preload drink; Other Names: Satiation study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Ghana
• Collaborators: University of Glasgow; University of Stirling
• Investigators: Principal Investigator: Eunice Nortey, University of Ghana

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Thinness
• Other Study ID Numbers: GHS-ERC:022/11/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data may be made available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No