Chicken liver and eggshell crackers as a safe and affordable animal source food for overcoming micronutrient deficits during pregnancy and lactation in Indonesia: a double-blind, randomised placebo-controlled trial (SISTIK Growth Study)

Aly Diana, Sofa Rahmannia, Yenni Zuhairini Suhadi, Dimas Erlangga Luftimas, Haidar Rizqi, Afini Dwi Purnamasari, Ayunda Jihadillah, Mohammad Brachim Ansari, Dearly Ayu Zahrotun Haq, Aisyah Nur Pratiwi, Samuel Scott, Daniela Hampel, Lindsay H Allen, Jillian J Haszard, Lisa A Houghton, Rosalind S Gibson, Umi Fahmida, Aly Diana, Sofa Rahmannia, Yenni Zuhairini Suhadi, Dimas Erlangga Luftimas, Haidar Rizqi, Afini Dwi Purnamasari, Ayunda Jihadillah, Mohammad Brachim Ansari, Dearly Ayu Zahrotun Haq, Aisyah Nur Pratiwi, Samuel Scott, Daniela Hampel, Lindsay H Allen, Jillian J Haszard, Lisa A Houghton, Rosalind S Gibson, Umi Fahmida

Abstract

Background: Indonesia ranks fifth in terms of the number of stunted children and there has been little change in the stunting prevalence in the last decade. In earlier observational studies conducted in 2014-2015, we identified several key underlying problems with the potential to impact stunting in Sumedang district, West Java, Indonesia. Deficits in intakes of growth-limiting micronutrients were observed, most notably calcium, iron, zinc, and vitamin A, emphasizing the need for a food-based intervention to overcome these micronutrient deficits in the diets of mothers and their infants. Methods: A double-blind placebo-controlled cluster randomised trial comparing the effect of daily consumption of 75 grams of locally produced micronutrient-enriched crackers (MEC) (intervention group) compared to placebo crackers (control group) by mothers at two-time intervals: (i) from the 8-14 weeks of pregnancy to delivery (i.e., 28-34 weeks of consumption of MEC) on birth length, and (ii) from the 8-14 weeks of pregnancy to 5 months post-partum on attained linear growth and linear growth velocity of breast-fed infants. A total of 324 pregnant women from 28 clusters (villages) located in 3 sub-districts in Sumedang district, West Java, Indonesia, will be randomly assigned to either intervention (n=14 villages) or control (n=14 villages). Discussi on: This will be the first study in Indonesia to use crackers based on powdered eggshells and chicken liver, in a form which is acceptable, safe, and has a long shelf life. If daily consumption of MEC for 6 months during pregnancy can enhance birth length, or their continued daily consumption for 5 months postpartum improves both attained and incremental linear growth at 5 months of age, then scaling-up in Indonesia may be considered. Trial Registration: https://ichgcp.net/clinical-trials-registry/NCT04564222 ; 25 th September 2020.

Keywords: Indonesia; food based intervention; lactation; linear growth; micronutrient deficiencies; pregnancy; stunting.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2022 Diana A et al.

Figures

Figure 1.. Study designs. MEC: Micronutrient-enriched Crackers.
Figure 1.. Study designs. MEC: Micronutrient-enriched Crackers.

References

    1. UNICEF: Improving child nutrition: the achievable imperative for global progress.New York: United Nations Children's Fund.2013;124.
    1. Leroy JL, Frongillo EA: Perspective: What Does Stunting Really Mean? A Critical Review of the Evidence. Adv Nutr. 2019;10(2):196–204. 10.1093/advances/nmy101
    1. Diana A, Haszard JJ, Purnamasari DM, et al. : Iron, zinc, vitamin A and selenium status in a cohort of Indonesian infants after adjusting for inflammation using several different approaches. Br J Nutr. 2017;118(10):830–839. 10.1017/S0007114517002860
    1. Daniels L, Gibson RS, Diana A, et al. : Micronutrient intakes of lactating mothers and their association with breast milk concentrations and micronutrient adequacy of exclusively breastfed Indonesian infants. Am J Clin Nutr. 2019;110(2):391–400. 10.1093/ajcn/nqz047
    1. Gibson RS, Rahmannia S, Diana A, et al. : Association of maternal diet, micronutrient status, and milk volume with milk micronutrient concentrations in Indonesian mothers at 2 and 5 months postpartum. Am J Clin Nutr. 2020;112(4):1039–50. 10.1093/ajcn/nqaa200
    1. Diana A, Purnamasari DM, Rahmannia S, et al. : Multimicronutrient Biomarkers Are Related to Anemia during Infancy in Indonesia: A Repeated Cross-Sectional Study. Curr Dev Nutr. 2019;3(5):nzz022. 10.1093/cdn/nzz022
    1. Diana A, Mallard SR, Haszard JJ, et al. : Consumption of fortified infant foods reduces dietary diversity but has a positive effect on subsequent growth in infants from Sumedang district, Indonesia. PLoS One. 2017;12(4):e0175952. 10.1371/journal.pone.0175952
    1. Rahmannia S, Diana A, Luftimas DE, et al. : Poor dietary diversity and low adequacy of micronutrient intakes among rural Indonesian lactating women from Sumedang district, West Java. PLoS One. 2019;14(7):e0219675. 10.1371/journal.pone.0219675
    1. Diana A, Haszard JJ, Sari SYI, et al. : Determination of modifiable risk factors for length-for-age z-scores among resource-poor Indonesian infants. PLoS One. 2021;16(2):e0247247. 10.1371/journal.pone.0247247
    1. McCormick BJJ, Murray-Kolb LE, Lee GO, et al. : Intestinal permeability and inflammation mediate the association between nutrient density of complementary foods and biochemical measures of micronutrient status in young children: results from the MAL-ED study. Am J Clin Nutr. 2019;110(4):1015–25. 10.1093/ajcn/nqz151
    1. National Institute of Health Research and Development (LITBANGKES) Republic of Indonesia: In: Basic Health Research (RISKESDAS). Jakarta: National Institute of Health Research and Development (LITBANGKES) Republic of Indonesia;2018.
    1. Schaafsma A, Pakan I, Hofstede GJ, et al. : Mineral, amino acid, and hormonal composition of chicken eggshell powder and the evaluation of its use in human nutrition. Poult Sci. 2000;79(12):1833–8. 10.1093/ps/79.12.1833
    1. Hawkes CP, Grimberg A: Insulin-Like Growth Factor-I is a Marker for the Nutritional State. Pediatr Endocrinol Rev. 2015;13(2):499–511.
    1. Seong PN, Cho SH, Park KM, et al. : Characterization of Chicken By-products by Mean of Proximate and Nutritional Compositions. Korean J Food Sci Anim Resour. 2015;35(2):179–88. 10.5851/kosfa.2015.35.2.179
    1. US DEPARTMENT OF AGRICULTURE: Chicken, liver, all classes, raw.2018.
    1. World Health Organization: Five keys to safer food manual. France: World Health Organization;2006.
    1. Centers for Disease Control and Prevention: Global Water, Sanitation, & Hygiene (WASH).2021.
    1. BPOM: PerKa BPOM no 21 tahun 2016. Kateg Pangan Indones.2016;1–28.
    1. Rahmannia S, Diana A, Luftimas DE, et al. : Poor dietary diversity and low adequacy of micronutrient intakes among rural Indonesian lactating women from Sumedang district, West Java. PLoS One. 2019;14(7):e0219675. 10.1371/journal.pone.0219675
    1. WHO/FAO: Human energy requirements. Report of a Joint FAO/WHO/UNU Expert Consultation. Rome: United Nations University, World Health Organization, Food and Agricultural Organization of the United Nations;2004.
    1. Institute of Medicine: Dietary Reference Intakes for calcium and vitamin D. Washington, DC: National Academies Press;2011.
    1. Institute of Medicine: Dietary Reference Intakes for vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: National Academies Press;2001.
    1. International Zinc Nutrition Consultative Group (IZiNCG); . Brown KH, Rivera JA, et al. : International Zinc Nutrition Consultative Group (IZiNCG) technical document #1. Assessment of the risk of zinc deficiency in populations and options for its control. Food Nutr Bull. 2004;25(1 Suppl 2):S99–203.
    1. World Health Organization: Anthropometry training video: the WHO multicenter growth reference study (DVD version). Geneva;2004.
    1. World Health Organization: Micronutrient survey manual. Geneva: World Health Organization;2020[cited 2022 Apr 28].
    1. Erhardt JG, Estes JE, Pfeiffer CM, et al. : Combined Measurement of Ferritin, Soluble Transferrin Receptor, Retinol Binding Protein, and C-Reactive Protein by an Inexpensive, Sensitive, and Simple Sandwich Enzyme-Linked Immunosorbent Assay Technique. J Nutr. 2004;134(11):3127–32. 10.1093/jn/134.11.3127
    1. Liu Z, Diana A, Slater C, et al. : Development of a nonlinear hierarchical model to describe the disposition of deuterium in mother-infant pairs to assess exclusive breastfeeding practice. J Pharmacokinet Pharmacodyn. 2019;46(1):1–13. 10.1007/s10928-018-9613-x
    1. I.A.E.A: Stable isotope technique to assess intake of human milk in breastfed infants. Vienna:International Atomic Energy Agency. (IAEA Human Health Series).2010;20175.
    1. E.I. Dupont & Co. Technical Literature: leaning Laboratory Plasticware.
    1. Meier PP, Engstrom JL, Zuleger JL, et al. : Accuracy of a user-friendly centrifuge for measuring creamatocrits on mothers’ milk in the clinical setting. Breastfeed Med. 2006;1(2):79–87. 10.1089/bfm.2006.1.79
    1. Sharpless KE, Schiller SB, Margolis SA, et al. : Certification of Nutrients in Standard Reference Material 1846: Infant Formula. J AOAC Int. 1997;80(3):611–21. 10.1093/jaoac/80.3.611
    1. Hampel D, Shahab-Ferdows S, Domek JM, et al. : Competitive chemiluminescent enzyme immunoassay for vitamin B12 analysis in human milk. Food Chem. 2014;153:60–5. 10.1016/j.foodchem.2013.12.033
    1. Hampel D, Dror DK, Allen LH: Micronutrients in Human Milk: Analytical Methods. Adv Nutr. 2018;9(suppl_1):313S–331S. 10.1093/advances/nmy017
    1. Hampel D, Shahab-Ferdows S, Islam MM, et al. : Vitamin concentrations in human milk vary with time within feed, circadian Rhythm, and single-dose supplementation. J Nutr. 2017;147(4):603–611. 10.3945/jn.116.242941
    1. LASER Analytica: Comprehensive literature search and review of breast milk composition as preparatory work for the setting of dietary reference values for vitamins and minerals. EFSA Support Publ. 2014;11(7):629E. 10.2903/sp.efsa.2014.EN-629
    1. Leong C, Gibson RS, Diana A, et al. : Differences in Micronutrient Intakes of Exclusive and Partially Breastfed Indonesian Infants from Resource-Poor Households are Not Accompanied by Differences in Micronutrient Status, Morbidity, or Growth. J Nutr. 2021;151(3):705–15. 10.1093/jn/nxaa381
    1. Menteri Kesehatan Republik Indonesia: Keputusan Menteri Kesehatan Republik Indonesia nomor 1452/Menkes/SK/X/2003 tentang Fortifikasi Tepung Terigu.2003.
    1. Dhamayanti M, Noviandhari A, Supriadi S, et al. : Association of maternal vitamin D deficiency and infants’ neurodevelopmental status: A cohort study on vitamin D and its impact during pregnancy and childhood in Indonesia. J Paediatr Child Health. 2020;56(1):16–21. 10.1111/jpc.14481
    1. Juwita F, Gumilang L, Risan NA, et al. : The Association of Vitamin D and Neurodevelopmental Status Among 2 Years Old Infants. Glob Pediatr Health. 2021;8:2333794X2110340. 10.1177/2333794X211034075
    1. W.H.O: Guideline: Delayed umbilical cord clamping for improved maternal and infant health and nutrition outcomes. Geneva:World Health Organization:2014.
    1. World Medical Association: World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–4. 10.1001/jama.2013.281053
    1. Badan Pengawas Obat dan Makanan: Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2019 tentang Batas Maksimal Cemaran Mikroba dalam Pangan Olahan.2019.
    1. Badan Pengawas Obat dan Makanan: Peraturan Badan Pengawas Obat dan Makanan Nomor 5 Tahun 2018 tentang Batas Maksimum Cemaran Logam Berat dalam Pangan Olahan.2018.
    1. European Food Safety Authority: Scientific Opinion on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans fatty acids, and cholesterol. EFSA J. 2010;8(3):1461. 10.2903/j.efsa.2010.1461
    1. World Health Organization: WHO child growth standards : growth velocity based on weight, length and head circumference : methods and development.2009;242.
    1. Campbell MK, Piaggio G, Elbourne DR, et al. : Consort 2010 statement: Extension to cluster randomised trials. BMJ. 2012;345(7881):e5661. 10.1136/bmj.e5661
    1. Menteri Kesehatan Republik Indonesia: Keputusan Menteri Kesehatan Republik Indonesia Nomor Hk.01.07/Menkes/382/2020 tentang Protokol Kesehatan bagi Masyarakat di Tempat dan Fasilitas Umum dalam Rangka Pencegahan dan Pengendalian Corona Virus Disease 2019 (Covid-19).2019.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit