An interventional study of High energy preload and Low energy preload in Underweight, Stunting and Healthy, sponsored by University of Ghana. Completed at 1 site in Ghana. Open to participants aged 12 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by University of Ghana · Not applicable, Interventional, and Basic science
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.
66 studies on the registry are indexed under Thinness; 11 are open to participants now.
This study's enrollment of 41 is below the median of 287 across 43 interventional studies indexed under Thinness.
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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
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 extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.
Also known as: Satiation study
Tests the amount participants eat at a meal following ingestion of a low energy preload drink
Also known as: Satiation study
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
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
Plan to share: No — Data may be made available on request
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Jul 2023, 14 months.
Of 22 interventional studies with no phase under Thinness, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 14 months is below that.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Ghana