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Energy Regulation and Nutritional Status of Children: A Satiation Study

Primary Purpose

Underweight, Stunting, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High energy preload
Low energy preload
Sponsored by
University of Ghana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Underweight

Eligibility Criteria

12 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • moderately malnourished (WHZ between -3 and -2 Z-scores) or stunted (HAZ<-2SD) or Healthy (WHZ >-2SD and HAZ >-2SD) children age 12-36 months.
  • Children should be attending child welfare clinics at the selected communities.
  • The children should be accompanied by a main caregiver who is actively involved in cooking for and/or feeding the child.
  • Children who are able to fast for at least 2 hours prior to the experiment.

Exclusion Criteria:

  • Children with congenital disorders, disabilities and diseases requiring specialised care and hospitalisation.
  • Children with severe malnutrition with complications that required inpatient care.
  • Tube-fed children.
  • Children who are both stunted and moderately malnourished

Sites / Locations

    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: sugar free ribena squash (2kcal/100ml) plus a weighed amount of super soluble maxijul. Super Soluble Maxijul is a powdered carbohydrate energy source, which can be mixed with sweet or savoury foods/ liquids. It is safe for use in both children and adults that require fortification with a high or readily available carbohydrate. It is flavourless and tasteless offering little to no change in taste, flavor and texture of food being added to. It supplies 380 kcal energy per 100g powder. The amount given will supply 10% of the child's daily energy requirements per Kg - for example a 3-year old child weighing about 16 kg requires approximately 1300 kcal/day. Hence the high energy drink will supply the child with 130kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat standardized weighed buffet lunch 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: sugar free ribena squash containing 2kcal per 100ml. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing the same range of weighed buffet foods as above.

    Outcomes

    Primary Outcome Measures

    Compensation index (Compx)
    The difference in energy consumed after high compared to low energy preload as percent of energy in preload. This will be calculated using a mathematical formulae: Compx = [ (energy from meal following low energy preload - energy from meal after high energy preload) / (energy from high energy preload - energy from low energy preload) ] x 100%

    Secondary Outcome Measures

    Difference in total energy consumed
    The total amount of energy consumed from preload plus test meal after high compared to low energy preload

    Full Information

    First Posted
    April 14, 2022
    Last Updated
    April 25, 2022
    Sponsor
    University of Ghana
    Collaborators
    University of Glasgow, University of Stirling
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05346549
    Brief Title
    Energy Regulation and Nutritional Status of Children: A Satiation Study
    Official Title
    Energy Regulation and Nutritional Status of Children: A Satiation Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2, 2022 (Anticipated)
    Primary Completion Date
    July 31, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    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 study among children attending child welfare clinics in Greater Accra Region of Ghana. The investigators want to find out if moderately malnourished children regulate the food energy intake similarly to healthy children, using an established method to assess energy compensation.
    Detailed Description
    Malnutrition originates from a complex interplay between genes and environment, manifesting in changes to hormones, metabolism, and behaviour. Energy regulation which determines food intake or avoidance plays a significant role in the cause, prevention and treatment of malnutrition. There is however limited knowledge of how energy regulation develops in children and its effect on their nutritional status in the context of undernutrition in children. A good understanding of energy regulation in children is therefore essential in designing interventions for tackling infant malnutrition. A standardised energy compensation study will be undertaken in 60 children- 20 moderately malnourished, 20 stunted and 20 healthy. 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
    Underweight, Stunting, Healthy

    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
    ParticipantInvestigator
    Masking Description
    Two similar tasting drinks will be used in random order, one low and one high energy after a standardized meal. The weight of food consumed will be measured by an observer blind to which supplement has been used.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High energy
    Arm Type
    Experimental
    Arm Description
    Child will be given a high energy drink: sugar free ribena squash (2kcal/100ml) plus a weighed amount of super soluble maxijul. Super Soluble Maxijul is a powdered carbohydrate energy source, which can be mixed with sweet or savoury foods/ liquids. It is safe for use in both children and adults that require fortification with a high or readily available carbohydrate. It is flavourless and tasteless offering little to no change in taste, flavor and texture of food being added to. It supplies 380 kcal energy per 100g powder. The amount given will supply 10% of the child's daily energy requirements per Kg - for example a 3-year old child weighing about 16 kg requires approximately 1300 kcal/day. Hence the high energy drink will supply the child with 130kcal. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat standardized weighed buffet lunch 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: sugar free ribena squash containing 2kcal per 100ml. They will be given 10 minutes to drink the preload and 30 minutes after this they will eat lunch containing the same range of weighed buffet 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 food 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
    Primary Outcome Measure Information:
    Title
    Compensation index (Compx)
    Description
    The difference in energy consumed after high compared to low energy preload as percent of energy in preload. This will be calculated using a mathematical formulae: Compx = [ (energy from meal following low energy preload - energy from meal after high energy preload) / (energy from high energy preload - energy from low energy preload) ] x 100%
    Time Frame
    calculated on second visit (1-4 weeks after first visit) after consumption of second test meal
    Secondary Outcome Measure Information:
    Title
    Difference in total energy consumed
    Description
    The total amount of energy consumed from preload plus test meal after high compared to low energy preload
    Time Frame
    calculated on second visit (1-4 weeks after first visit) after consumption of second test meal

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: moderately malnourished (WHZ between -3 and -2 Z-scores) or stunted (HAZ<-2SD) or Healthy (WHZ >-2SD and HAZ >-2SD) children age 12-36 months. Children should be attending child welfare clinics at the selected communities. The children should be accompanied by a main caregiver who is actively involved in cooking for and/or feeding the child. Children who are able to fast for at least 2 hours prior to the experiment. Exclusion Criteria: Children with congenital disorders, disabilities and diseases requiring specialised care and hospitalisation. Children with severe malnutrition with complications that required inpatient care. Tube-fed children. Children who are both stunted and moderately malnourished
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eunice Nortey
    Phone
    +233246046253
    Email
    eunicearthur@rocketmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eunice Nortey
    Organizational Affiliation
    University of Ghana
    Official's Role
    Principal Investigator

    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

    Energy Regulation and Nutritional Status of Children: A Satiation Study

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