Satiation Study With Children Attending a Tertiary Feeding Clinic

NCT04851327 | Completed

• 1 other identifier: NHSGGC290906
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernutrition; Underweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total energy consumed per study day

  Calculated on day 8, after consumption of 2nd test meal

Study Arms (2)

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.

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.

Behavioral: Low energy preload; Behavioral: Test meal

Interventions

High Energy preload BEHAVIORAL

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

Also known as: Satiation study

High energy

Low energy preload BEHAVIORAL

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

Also known as: Satiation study

Low energy

Test meal BEHAVIORAL

Test meal to follow low or high energy preload

High energy; Low energy

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• University of Stirling: collaborator
• University of Ghana: collaborator

Study Sites (1)

New Lister building, Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition; Thinness

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte M Wright, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Community Child Health

Model Details: cross-over energy compensation study, participants acting as their own controls

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 20, 2021
• Study Start: May 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)