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Satiation Study With Children Attending a Tertiary Feeding Clinic

Primary Purpose

Undernutrition, Underweight

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Energy preload
Low energy preload
Test meal
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Undernutrition

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • New Lister building, Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High energy

Low energy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Compensation index
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
The total amount of energy consumed form preload plus meal after high compared to low energy preload

Full Information

First Posted
April 12, 2021
Last Updated
March 29, 2022
Sponsor
University of Glasgow
Collaborators
University of Stirling, University of Ghana
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1. Study Identification

Unique Protocol Identification Number
NCT04851327
Brief Title
Satiation Study With Children Attending a Tertiary Feeding Clinic
Official Title
Behavioural Correlates of Wasting: a Pilot Satiation Study With Children Attending a Tertiary Feeding Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
University of Stirling, University of Ghana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Underweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
cross-over energy compensation study, participants acting as their own controls
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High energy
Arm Type
Experimental
Arm Description
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.
Arm Title
Low energy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High Energy preload
Other Intervention Name(s)
Satiation study
Intervention Description
Tests the extent to which participants reduce their intake at a meal following ingestion of a high energy preload drink
Intervention Type
Behavioral
Intervention Name(s)
Low energy preload
Other Intervention Name(s)
Satiation study
Intervention Description
Tests the amount participants eat at a meal following ingestion of a low energy preload drink
Intervention Type
Behavioral
Intervention Name(s)
Test meal
Intervention Description
Test meal to follow low or high energy preload
Primary Outcome Measure Information:
Title
Compensation index
Description
The difference in energy consumed after high compared to low energy preload as percent of energy in preload
Time Frame
Calculated on day 8, after consumption of 2nd test meal
Secondary Outcome Measure Information:
Title
total energy consumed per study day
Description
The total amount of energy consumed form preload plus meal after high compared to low energy preload
Time Frame
Calculated on day 8, after consumption of 2nd test meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte M Wright, MD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Lister building, Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data may be made available on request

Learn more about this trial

Satiation Study With Children Attending a Tertiary Feeding Clinic

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