UndernutritionNCT04851327
Satiation Study With Children Attending a Tertiary Feeding Clinic
A study testing High Energy preload, Low energy preload and Test meal in people with Undernutrition and Underweight, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after children with severe feeding problems who commonly have low appetite and extreme thinness. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Undernutrition, Underweight
- What is being tested?
- High Energy preload, Low energy preload and Test meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 31 Aug 2021
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Currently attending Glasgow Feeding Clinic or seen within the last 2 years.
- Completed ICFET questionnaire and eating solid food at least weekly.
- Body mass index < 9th centile.
- Within 40 minutes car travel from study centre
Who cannot join
- Patient or family member shielding from COVID.
- Not able to swallow safely
- Not taking solid foods
- Fully tube fed: i.e. receiving more than 75% of energy requirements from tube feeding.
- No measurements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
New Lister building, Royal Infirmary
Glasgow, Scotland, G31 2ER
About this study
Official title: Behavioural Correlates of Wasting: a Pilot Satiation Study With Children Attending a Tertiary Feeding Clinic
This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if thin children respond to food in the same way, using an established method to assess energy compensation.
Read the detailed description
Thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. There is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness.
A Ghanaian student will come to Glasgow, funded by the Glasgow University /Scottish funding council Global Challenges Research fund, to learn these techniques to use in future PhD research. The student will conduct a pilot study of children attending the GFC. The student will invite 40 families to complete our standardised online questionnaire (ICFET) about their child's eating behaviour and collate existing growth measurements as well as their feeding history.
A standardised energy compensation study will then be undertaken in 20 of the thinnest children. 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
- Undernutrition, Underweight
- Being tested
- High Energy preload, Low energy preload, Test meal
- Medical subject headings
- Malnutrition, Thinness
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 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
Test mealBehavioural
Test meal to follow low or high energy preload
| Study group | Role | What they receive |
|---|---|---|
| High energy | Experimental | Child will be given a high energy drink: a flavoured high energy milk or juice-based drink, used clinically to supplement the diet of preschool children (either Pediasure plus or Duocal). This will provide 1.5 kcals per ml in various flavours as preferred. The amount given will supply 10% of the child's daily energy requirements per Kg - for example for a 2-year-old child weighing 15 KG this would be 80 mls of drink supplying 120 Kcal.
They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing a range of pre-packaged foods of known energy content suitable for their age, chosen in consultation with the parents. Receives: Behavioral: High Energy preload; Behavioral: Test meal |
| 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, made either of skim milk or sugar free fruit juice, with a similar sugar free flavour; for above example this will supply 25 kcal.
They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing the same range of pre-packaged foods as above. Receives: Behavioral: Low energy preload; Behavioral: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compensation index
The difference in energy consumed after high compared to low energy preload as percent of energy in preload
Measured: Calculated on day 8, after consumption of 2nd test meal
Secondary outcomes (1)
total energy consumed per study day
The total amount of energy consumed form preload plus meal after high compared to low energy preload
Measured: Calculated on day 8, after consumption of 2nd test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 May 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies 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, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stirling, University of Ghana
- Responsible party
- Principal investigator, Charlotte Wright, University of Glasgow
- Investigators
- Charlotte M Wright, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851327
- Sponsor's protocol ID
- NHSGGC290906
- Status last verified
- Mar 2022
- First submitted
- 12 Apr 2021
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Correlates of Wasting: a Pilot Satiation Study With Children Attending a Tertiary Feeding Clinic
- ClinicalTrials.gov ID
- NCT04851327
- Acronym / sponsor ID
- NHSGGC290906
- Conditions
- Undernutrition, Underweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- University of Stirling, University of Ghana
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 20 Apr 2021 (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 a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if thin children respond to food in the same way, using an established method to assess energy compensation.
Detailed description
Thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. There is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness.
A Ghanaian student will come to Glasgow, funded by the Glasgow University /Scottish funding council Global Challenges Research fund, to learn these techniques to use in future PhD research. The student will conduct a pilot study of children attending the GFC. The student will invite 40 families to complete our standardised online questionnaire (ICFET) about their child's eating behaviour and collate existing growth measurements as well as their feeding history.
A standardised energy compensation study will then be undertaken in 20 of the thinnest children. 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, outcomes assessor)
- 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 preload, Behavioral: Test mealChild will be given a high energy drink: a flavoured high energy milk or juice-based drink, used clinically to supplement the diet of preschool children (either Pediasure plus or Duocal). This will provide 1.5 kcals per ml in various flavours as preferred. The amount given will supply 10% of the child's daily energy requirements per Kg - for example for a 2-year-old child weighing 15 KG this would be 80 mls of drink supplying 120 Kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing a range of pre-packaged foods of known energy content suitable for their age, chosen in consultation with the parents. |
| Low energy | Experimental | Behavioral: Low energy preload, Behavioral: Test mealChild will be given a low energy drink of the same volume selected to be as similar as possible to the high energy drink, made either of skim milk or sugar free fruit juice, with a similar sugar free flavour; for above example this will supply 25 kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing the same range of pre-packaged foods as above. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Currently attending Glasgow Feeding Clinic or seen within the last 2 years.
- Completed ICFET questionnaire and eating solid food at least weekly.
- Body mass index < 9th centile.
- Within 40 minutes car travel from study centre
Key exclusion criteria (5 listed)
- Patient or family member shielding from COVID.
- Not able to swallow safely
- Not taking solid foods
- Fully tube fed: i.e. receiving more than 75% of energy requirements from tube feeding.
- No measurements
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 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 |
| Test mealTest meal to follow low or high energy preload | Behavioural | High energy, Low energy |
Primary outcome
Compensation index
Time frame: Calculated on day 8, after consumption of 2nd test meal
The difference in energy consumed after high compared to low energy preload as percent of energy in preload
1 secondary outcome
total energy consumed per study day
Time frame: Calculated on day 8, after consumption of 2nd 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 7 Apr 2022.
- 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.
Charlotte M Wright, MD principal investigator
University of Glasgow
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, Low energy preload and Test meal in people with Undernutrition and Underweight, run by University of Glasgow at 1 site in United Kingdom.
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 5 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 7 Apr 2022. 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 United Kingdom. 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 (time frame: Calculated on day 8, after consumption of 2nd 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 7 Apr 2022.