Nutritional Deficiency Clinical Trial
Official title:
Association Between Intakes of Protein, Calcium, and Milk With Gene Expression and Linear Growth of School Aged Children in Malang
Verified date | December 2019 |
Source | SEAMEO Regional Centre for Food and Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 10 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Universitas Brawijaya | Malang | East Java |
Lead Sponsor | Collaborator |
---|---|
SEAMEO Regional Centre for Food and Nutrition | Direktorat Riset dan Pengabdian Masyarakat Universitas Indonesia, University of Brawijaya |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | nutrient intakes | Dietary of energy intake, macronutrients, calcium and other micronutrients related to growth will be assessed using 24-hour recall with multiple-pass interviewing technique. The analysis will be performed using Nutrisurvey 2017 with Indonesian food composition table. | 3 days in baseline and end-line | |
Secondary | VDR Gene Polymorphism of SNP rs4516035 and rs11568820 | The SNP Genotyping assay analyzed using Real Time PCR and StepOne V2.3 Software. A total of 40 cycles will performed. The cycling steps of the analysis are Hold (95oC, 20s), Denaturation (95oC, 3s), Annealing Extension (60oC, 20s). The total running time was about one and a half hours for 40 cycles. | in middle of study (2 months after baseline) | |
Secondary | gene expression of mTORC1 pathway | The expression of 5' TOP genes as biomarker of downstream mTORC1 pathway will be analyzed using RT-qPCR and StepOne V2.3 Software. mRNA quantified by SYBR Green reaction. A total of 40 cycles will performed. The cycling steps of the analysis are UDG activation (50oC, 2min), Dual-Lock DNA polymerase (95oC, 2min), Denaturation (95oC, 3s), Annealing Extension (60oC, 30s). The total running time was about half an hour for 40 cycles. | 3 days in end-line of study |
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