UnderweightNCT05346549
Energy Regulation and Nutritional Status of Children: A Satiation Study
A study testing High energy preload and Low energy preload in people with Underweight and Stunting, run by University of Ghana at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Underweight, Stunting, Healthy
- What is being tested?
- High energy preload and Low energy preload
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGhana
- Study dates
- 2 May 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Underweight, Stunting, Healthy
- Being tested
- High energy preload, Low energy preload
- Medical subject headings
- Thinness, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High energy preloadBehavioural
Also called Satiation study
Tests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.
Low energy preloadBehavioural
Also called Satiation study
Tests the amount participants eat at a meal following ingestion of a low energy preload drink
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Low energy preload |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
Secondary outcomes (1)
Difference in total energy consumed
The total amount of energy consumed from preload plus test meal after high compared to low energy preload
Measured: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start2 May 2022
- Primary completion31 Jul 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- cross-over energy compensation study, participants acting as their own controls
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, University of Stirling
- Responsible party
- Principal investigator, Eunice Nortey, University of Ghana
- Investigators
- Eunice Nortey, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346549
- Sponsor's protocol ID
- GHS-ERC:022/11/21
- Status last verified
- Jan 2024
- First submitted
- 14 Apr 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Regulation and Nutritional Status of Children: A Satiation Study
- ClinicalTrials.gov ID
- NCT05346549
- Acronym / sponsor ID
- GHS-ERC:022/11/21
- Conditions
- Underweight, Stunting, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of GhanaUniversity, hospital or other
- Collaborators
- University of Glasgow, University of Stirling
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- cross-over energy compensation study, participants acting as their own controls
| Arm | Type | Receives |
|---|---|---|
| High energy | Experimental | Behavioral: High energy preloadChild 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. |
| Low energy | Experimental | Behavioral: Low energy preloadChild 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. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High energy preloadAlso: Satiation studyTests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink. | Behavioural | High energy |
| Low energy preloadAlso: Satiation studyTests the amount participants eat at a meal following ingestion of a low energy preload drink | Behavioural | Low energy |
Primary outcome
Compensation index (Compx)
Time frame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
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%
1 secondary outcome
Difference in total energy consumed
Time frame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No. Data may be made available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunice Nortey principal investigator
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High energy preload and Low energy preload in people with Underweight and Stunting, run by University of Ghana at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compensation index (Compx) (time frame: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.