Clinical trial NCT06287697: Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia
Official title: Determination of Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia Using the Doubly-Labelled Water (DLW) Technique
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Energy Expenditure
Body Composition
Infants and Young Children
Infant and Young Child Feeding
Keywords: Total energy expenditure
Fat mass
Fat-free mass
Doubly-labelled water
Children aged 6-24 months
Infant and young child feeding
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: International Atomic Energy Agency
name: National Institute of Nutrition, Vietnam
name: Faculty of Medicine, University of Ruhuna, Sri Lanka
name: Pakistan Institute of Nuclear Science and Technology (PINSTECH)
name: Food and Nutrition Research Institute, Philippines
name: FAO
First posted: 2024-03-01
Enrollment: 391
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Apparently healthy infants and young children aged 6-23 months of both sexes, belonging to the major ethnicity of the country, and having any socio-economic status.

Brief summary: This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

Detailed description: The current international recommendations on energy requirements for children aged 6-24 months were established based on data from the Western populations. More human data of healthy children from the developing countries where the living conditions may not be as favourable for child growth and development would be needed to ascertain the validity of the global recommendation. The role of the doubly-labelled water (DLW) technique in measuring total daily energy expenditure to derive energy requirements for humans was also highlighted. Low and middle income countries in Asian countries have undergone the nutrition transition and malnutrition on both ends of the spectrum emerge as significant nutrition challenges during this critical period of growth. Unfortunately, data on body composition, i.e., the relative amounts of fat and lean or fat-free tissue which constitutes quality normal growth beyond anthropometric measurements are scarce. These data will also be needed to guide the infant and young child feeding (IYCF) recommendations for good nutrition and health and to prevent all forms of malnutrition in the region.

This project addressed the need to fill the information gap for the region, and potentially be included for making revision on energy requirement recommendations for infants and young children (IYC) for Asia and beyond. Building on the previous technical cooperation between institutions in Southeast and South Asia with the International Atomic Energy Agency (IAEA) on stable isotopic techniques for health and nutrition well-being, this project is a collaboration between IAEA, FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

Eligibility criteria: Inclusion Criteria for Mothers:

* Being aged \>18 y old
* Being non-smoker
* Gestational age at delivery 37-41weeks
* Belonging to the major ethnicity of the country
* Having any socio-economic status
* Willing to sign informed written consent

Inclusion Criteria for Infants:

* Healthy baby
* Full term
* Having birth weight between 2.5 and 4.0 kg
* Height-for-age Z score and weight-for-height Z score at or above -2SD
* Being exclusively or predominantly breast-fed for at least 3 months

Exclusion Criteria for Mothers:

* Mothers: having chronic diseases, e.g., gestational diabetes were excluded.

Exclusion Criteria for Infants:

* Having inborn errors or chronic diseases e.g., celiac diseases
* Taking special supplement, e.g., RUTF.

Primary outcomes:
measure: Total Energy Expenditure
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Body composition
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary outcomes:
measure: Weight
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Length
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Head circumference
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Mid-upper arm circumference
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Triceps skinfold thickness
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Subscapular skinfold thickness
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Infant and Young Child Feeding (IYCF)
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
measure: Dietary intake
timeFrame: assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Institute of Nutrition, Mahidol University
state: Nakhon Pathom
Study officials:
affiliation: Mahidol University
name: Tippawan Pongcharoen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ua-Areechit T, Suteerojntrakool O, Pongcharoen T, Winichagoon P, Judprasong K, Murphy-Alford AJ, Lee WTK, Potip B, Sridonpai P, Tongchom W, Chomtho S. Breastfeeding duration is associated with higher adiposity at 6-8 months of age. Matern Child Nutr. 2023 Jan;19(1):e13438. doi: 10.1111/mcn.13438. Epub 2022 Oct 18.