Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia

Body Composition Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06287697
• Other study ID #: LOA/RAP/2019/20
• Status: Active, not recruiting
• Start date: January 21, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 391
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Body Composition
• Energy Expenditure
• Infant and Young Child Feeding

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Thailand	Institute of Nutrition, Mahidol University	Salaya	Nakhon Pathom

Sponsors (7)

Lead Sponsor	Collaborator
Mahidol University	Faculty of Medicine, University of Ruhuna, Sri Lanka, FAO, Food and Nutrition Research Institute, Philippines, International Atomic Energy Agency, National Institute of Nutrition, Vietnam, Pakistan Institute of Nuclear Science and Technology (PINSTECH)

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Energy Expenditure	Total Energy Expenditure assessed using doubly labelled water (DLW) technique	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Primary	Body composition	Body composition assessed using doubly labelled water (DLW) technique	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Weight	Body weight of infants in kilograms	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Length	Lenght of infants in centimeters	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Head circumference	Head circumference of infants in centimeters	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Mid-upper arm circumference	Mid-upper arm circumference of the left arm in centimeters	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Triceps skinfold thickness	Triceps skinfold thickness of the left arm in millimeters	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Subscapular skinfold thickness	Subscapular skinfold thickness of the left side in millimeters	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Infant and Young Child Feeding (IYCF)	IYCF indicators were determined using the IYCF questionnaire IYCF practices were assessed using the IYCF , breast milk intake, dietary intake	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months
Secondary	Dietary intake	24-hr recall was administered for 3 days to obtain nutrient intakes from breast milk and diet	assessed at aged 6-8, 9-11, 12-14, 15-17, 18-20, and 21-23 months