Association Between Intakes of Protein, Calcium and Milk With Gene Expression and Linear Growth of School Aged Children

NCT03895151 | Completed

• 1 other identifier: NGMilkMalang
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Protein is one type of nutrients known as the cause of stunting in developing countries since the mid-1970s (1) but then less attention on protein intake with the assumption that protein intake is sufficient. Compilation of published and non-published dietary intake research among Indonesian children aged 3-12 years (2), 0-18 years old (3) and 1-3 years old (3) found that protein intake among Indonesian children was sufficient (4). This finding is also confirmed by some other studies in 6 low-income countries and lead to the conclusion that growth restriction is not due to protein deficiency (5). Since then, micronutrient received main attention for the past 4 decades (1) to improve the health and survival of young children in developing countries. Issues on the need to re-examined protein recently emerge after the paper of Semba (1,6) regarding the low circulating amino acid among stunted children. It was hypothesized that the correlation between the low level of circulating amino acid with linear growth was through the mechanism of rapamycin complex C1 (mTORC1) and general control nonderepressible 2 (GCN2) pathway that contributes in the synthesis of sphingolipids and glycerophospholipids (6). However, the mechanism on how amino acid link to linear growth remains unclear. Fortification among Asian children revealed that only milk as food vehicles reported a significant effect on linear growth (2). It is likely that the effect on linear growth is influenced not only on micronutrient content of the fortified foods but also on protein and amino acid profiles of milk as the food vehicle.

Conditions

Nutritional Stunting; Nutritional Anemia; Nutritional Deficiency; Nutrigenetic; Nutrigenomic; Linear Programming; Food Based Recommendation

Outcome Measures

Primary Outcomes (1)

• Increasing of children height who receive intervention from baseline

  Height of the subject will be measured using Shorrboard. Height measurement will be taken twice, the difference between 1st and 2nd measurements should be not more than 0.7 cm. The data analyzed using WHO AnthroPlus to obtain height for age z-score (HAZ) of the subject.

  3 days in end-line of study

Secondary Outcomes (3)

• nutrient intakes

  3 days in baseline and end-line

• VDR Gene Polymorphism of SNP rs4516035 and rs11568820

  in middle of study (2 months after baseline)

• gene expression of mTORC1 pathway

  3 days in end-line of study

Study Arms (3)

Milk supplementation

EXPERIMENTAL

Children will receive 130 ml fresh milk, 6 days/week for 20 weeks (January-June 2019). Milk will be provided and delivered by appointed supplier directly to school. Milk will be distributed with name of the student on the bottle - during break time. Subjects must be consumed with supervision of the teacher at school during the break. If they can not finish the milk at once, they can store it in the provided cool box. Student then can consume it again before they go home. Teacher have to record the remaining milk in each bottle that corresponds to every child name and record it in the provided form. Prior to holiday, student will be given the milk according to school leave days. Enumerators should collect the form every 3 days and make a recap in the provided form.

Dietary Supplement: Milk supplementation

Food Based Recommendation (FBR) nutrition education

EXPERIMENTAL

FBR group will received nutrition education delivered by trained teacher under the supervision of researcher/research assistant once a week. Those who received nutrition education is not only the recruited subjects but also includes their classmates.

Other: Food Based Recommendation (FBR) nutrition education

Control

NO INTERVENTION

Control group will receive standard nutrition education

Interventions

Milk supplementation DIETARY_SUPPLEMENT

Fresh milk from local farmer. No artificial sweetener and preservatives. Brandless.

Milk supplementation

Food Based Recommendation (FBR) nutrition education OTHER

Food Based Recommendation is result of OPTIFOOD WHO that analysed local food to optimize nutritional status according to problem nutrient.

Food Based Recommendation (FBR) nutrition education

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary school children
• Willing to take part in the research and taken venous blood sampling as evidence by the signing of an informed consent from the parents
• Does not suffer from disability
• No complaint such as diarrhea, vomiting or nausea after drinking milk (based on the information of parents during screening)

You may not qualify if:

• The child not present when taking blood
• Having a history of bleeding such as hemophilia
• Children have plans to move schools within the next 6 months from the baseline data collection.

Sponsors & Collaborators

• SEAMEO Regional Centre for Food and Nutrition: lead
• Direktorat Riset dan Pengabdian Masyarakat Universitas Indonesia: collaborator
• University of Brawijaya: collaborator

Study Sites (1)

Universitas Brawijaya

Malang, East Java, 65145, Indonesia

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Umi Fahmida Fahmida, Dr

  SEAMEO RECFON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Umi Fahmida

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: March 29, 2019
• Study Start: January 24, 2018
• Primary Completion: June 15, 2019
• Study Completion: June 30, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

ID (1)