Energy Regulation and Nutritional Status of Children: A Satiation Study

NCT05346549 | Completed

• 1 other identifier: GHS-ERC:022/11/21
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Underweight; Stunting; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in total energy consumed

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

Study Arms (2)

High energy

EXPERIMENTAL

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

Low energy

EXPERIMENTAL

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

Interventions

High energy preload BEHAVIORAL

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

Also known as: Satiation study

High energy

Low energy preload BEHAVIORAL

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

Also known as: Satiation study

Low energy

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ghana: lead
• University of Glasgow: collaborator
• University of Stirling: collaborator

Study Sites (1)

University of Ghana

Accra, Ghana

Location

MeSH Terms

Conditions

Thinness; Growth Disorders

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Eunice Nortey

  University of Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 26, 2022
• Study Start: May 2, 2022
• Primary Completion: July 31, 2023
• Study Completion: October 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)