Energy Regulation and Nutritional Status of Children: A Satiation Study
NCT ID: NCT05346549
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2022-05-02
2023-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
High energy preload
Tests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.
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.
Low energy preload
Tests the amount participants eat at a meal following ingestion of a low energy preload drink
Interventions
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High energy preload
Tests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.
Low energy preload
Tests the amount participants eat at a meal following ingestion of a low energy preload drink
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 severe malnutrition with complications that required inpatient care.
* Tube-fed children.
* Children who are both stunted and moderately malnourished
12 Months
36 Months
ALL
Yes
Sponsors
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University of Glasgow
OTHER
University of Stirling
OTHER
University of Ghana
OTHER
Responsible Party
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Eunice Nortey
Principal Investigator
Principal Investigators
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Eunice Nortey
Role: PRINCIPAL_INVESTIGATOR
University of Ghana
Locations
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University of Ghana
Accra, , Ghana
Countries
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Other Identifiers
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GHS-ERC:022/11/21
Identifier Type: -
Identifier Source: org_study_id
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