Satiation Study With Children Attending a Tertiary Feeding Clinic

Sponsor

University of Glasgow (Other)

Overall Status

Completed

CT.gov ID

NCT04851327

Collaborator

University of Stirling (Other), University of Ghana (Other)

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Undernutrition Underweight	Behavioral: High Energy preload Behavioral: Low energy preload Behavioral: Test meal	N/A

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

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

cross-over energy compensation study, participants acting as their own controlscross-over energy compensation study, participants acting as their own controls

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Two similar tasting drinks will be used in random order, one low and one high energy After a standardised meal, the weight of food consumed will be measured by an observer blind to which supplement has been used

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High energy 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.	Behavioral: High Energy preload Tests the extent to which participants reduce their intake at a meal following ingestion of a high energy preload drink Other Names: Satiation study Behavioral: Test meal Test meal to follow low or high energy preload
Experimental: 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, 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.	Behavioral: Low energy preload Tests the amount participants eat at a meal following ingestion of a low energy preload drink Other Names: Satiation study Behavioral: Test meal Test meal to follow low or high energy preload

Arm

Intervention/Treatment

Experimental: High energy

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.

Behavioral: High Energy preload

Tests the extent to which participants reduce their intake at a meal following ingestion of a high energy preload drink

Other Names:

Satiation study

Behavioral: Test meal

Test meal to follow low or high energy preload

Experimental: 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, 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.

Behavioral: Low energy preload

Tests the amount participants eat at a meal following ingestion of a low energy preload drink

Other Names:

Satiation study

Behavioral: Test meal

Test meal to follow low or high energy preload

Outcome Measures

Primary Outcome Measures

Compensation index [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

Secondary Outcome Measures

total energy consumed per study day [Calculated on day 8, after consumption of 2nd test meal]
The total amount of energy consumed form preload plus meal after high compared to low energy preload

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Lister building, Royal Infirmary	Glasgow	Scotland	United Kingdom	G31 2ER

Sponsors and Collaborators

University of Glasgow
University of Stirling
University of Ghana

Investigators

Principal Investigator: Charlotte M Wright, MD, University of Glasgow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Charlotte Wright, Professor of Community Child Health, University of Glasgow

ClinicalTrials.gov Identifier:

NCT04851327

Other Study ID Numbers:

NHSGGC290906

First Posted:

Apr 20, 2021

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Thinness

Study Results

No Results Posted as of Apr 7, 2022