Practice of Nutrition Package in Myanmar

NCT06827964 | Not Yet Recruiting

• 1 other identifier: THU01-20240170
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this cluster randomized controlled trial is to study the effectiveness of the Nutrition Package (Yingyangbao) on improving malnutrition in children and adolescents aged 7-15 in Myanmar. The main questions it aims to answer are:

• What is the effectiveness of Nutrition Package intervention on the growth, development, and nutritional health of children and adolescents aged 7-15 in Myanmar?
• How safe and feasible is the Nutrition package? Researchers will compare the Nutrition Package plus probiotics, the Nutrition Package alone, and no intervention to see if the Nutrition Package improves malnutrition and other health outcomes of children and adolescents aged 7-15 in Myanmar. Participants will receive Nutrition Package products for six months and have their height, weight, mid-upper arm circumference, and hemoglobin levels measured and compared at baseline and end.

Conditions

Malnutrition in Children

Keywords

Nutrition Package; Malnutrition; Myanmar

Outcome Measures

Primary Outcomes (1)

• Physical examination

  Height and weight are measured using a height and weight meter, and mid-upper arm circumference is measured using an arm circumference ruler.

  At the enrollment, later 3 month and later 6 month.

Secondary Outcomes (1)

• Hemoglobin determination

  At the enrollment, later 3 month and later 6 month.

Study Arms (3)

Group 1

EXPERIMENTAL

Nutrition Package plus Probiotics

Dietary Supplement: Soy-based Nutrition Package; Dietary Supplement: Probiotics

Group 2

EXPERIMENTAL

Nutrition package alone

Dietary Supplement: Soy-based Nutrition Package

Group 3

NO INTERVENTION

Blank control

Interventions

Soy-based Nutrition Package DIETARY_SUPPLEMENT

Dry, vacuum-sealed sachets containing yellow powder, odorless, to be consumed with warm water. Each 12g sachet provides: 209 kJ energy, 3.1g protein, 1.7g fat, 4.6g carbohydrates, 3mg sodium, 200mg calcium, 7.5mg iron, 3mg zinc, 250μg RE vitamin A, 5μg vitamin D, 0.5mg vitamin B1, 0.5mg vitamin B2, 0.5μg vitamin B12, and 75μg folate. Intervention duration: 6 months, with 2 sachets per day. Produced by Tiantianai (Jiangsu) Biotechnology Co., Ltd., a certified supplier for maternal and child nutrition projects in China.The company has a Class D production workshop that meets the latest GMP standards for pharmaceuticals. The product has passed certifications for Food Safety Management System (ISO 22000) and Quality Management System (ISO 9001).

Also known as: Yingyangbao

Group 1; Group 2

Probiotics DIETARY_SUPPLEMENT

Dry, vacuum-sealed sachets containing white powder, odorless. Each 2g sachet contains 500\*10\^9 CFU of Lactobacillus plantarum LLY-606 and Pediococcus pentosaceus JQI-7. Intervention duration: 6 months, with 1 sachet per day. Produced by Jiangsu Wecare Biotechnology Co., Ltd., compliant with international standards (cGMP, FSSC 22000, HACCP, ISO 22000, ISO 9001).

Group 1

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged 7-15 years.
• Residing in the local area for more than 1 year.

You may not qualify if:

• Individuals with severe metabolic diseases.
• Diagnosed with HIV/AIDS.
• Individuals with physical disabilities.
• Individuals with severe mental conditions that may hinder their ability to cooperate with the study.
• Those who have received other nutritional supplementation packages or fortified foods in the past 6 months.
• Individuals with a history of intestinal diseases, other severe digestive system disorders, or metabolic disorders.

Sponsors & Collaborators

• Tsinghua University: lead

Related Publications (1)

• Li Z, Li X, Sudfeld CR, Liu Y, Tang K, Huang Y, Fawzi W. The Effect of the Yingyangbao Complementary Food Supplement on the Nutritional Status of Infants and Children: A Systematic Review and Meta-Analysis. Nutrients. 2019 Oct 8;11(10):2404. doi: 10.3390/nu11102404.

  PMID: 31597360 BACKGROUND

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ai Zhao

  Vanke School of Public Health, Tsinghua University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jigen Na

CONTACT

+86 18569451615; njg23@mails.tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: March 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02