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Completed

NCT Number: NCT04851327

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.

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Key information

Conditions

Undernutrition Body Weight Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Underweight

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Lister building, Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Energy preload

Behavioral

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

Other names: Satiation study

Low energy preload

Behavioral

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

Other names: Satiation study

Test meal

Behavioral

Test meal to follow low or high energy preload

Primary outcomes

  1. 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

Secondary outcomes

  1. total energy consumed per study day

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • University of Ghana
  • University of Stirling

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2021
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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