Satiation Study With Children Attending a Tertiary Feeding Clinic

Undernutrition Clinical Trial

Official title:

Behavioural Correlates of Wasting: a Pilot Satiation Study With Children Attending a Tertiary Feeding Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04851327
• Other study ID #: NHSGGC290906
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators want to find out if thin children respond to food in the same way, using an established method to assess energy compensation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Malnutrition
• Thinness
• Undernutrition
• Underweight

Intervention

Behavioral:
• High Energy preload
Tests the extent to which participants reduce their 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
• Test meal
Test meal to follow low or high energy preload

Locations

Country	Name	City	State
United Kingdom	New Lister building, Royal Infirmary	Glasgow	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
University of Glasgow	University of Ghana, University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compensation index	The difference in energy consumed after high compared to low energy preload as percent of energy in preload	Calculated on day 8, after consumption of 2nd test meal
Secondary	total energy consumed per study day	The total amount of energy consumed form preload plus meal after high compared to low energy preload	Calculated on day 8, after consumption of 2nd test meal