The Effect of Functional Bread Dadih on Microbiota Profile of Weight Increase Pregnant Women and Infant Birth Weight

Birth Weight Clinical Trial

Official title:

The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712629
• Other study ID #: HL
• Status: Completed
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2023
• Source: Andalas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of study to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.

Description:

Dadih contains BAL 108 CFU/ml which is probiotic. Consumption of functional bread and dadih's vla during pregnancy can improve the composition of the gut microbiota so that it can increase maternal weight and provide adequate nutrition during pregnancy. Good nutrient absorption can support good nutritional status and weight in babies who are born. This study aims to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.

This study used a randomized controlled trial (RCT) design with a population of all pregnant women in the Kuranji, Nanggalo and Andalas Health Centers. The sample consisted of 88 people and was divided into two groups, namely the intervention group and the control group. Each amounted to 44 samples. The sample selection used the double-blind method and randomized controlled trial (RCT) research design. The intervention started at about 12-20 weeks of gestation and continued until just before the time of delivery. In the third trimester, subjects received healthy food, breastfeeding practices, and child development education to support mothers in maintaining their nutritional status, preparing exclusive breastfeeding, and optimizing child development.

Healthy babies born to mothers will be the focus of this study and followed up until the age of three months to assess their growth. The information includes the baby's health history after birth, anthropometric measurements, nutritional intake, and breastfeeding practices which are measured repeatedly in the first, second, and third months.

Data quality assurance is carried out through training starting from the period of data collection and supervision during and after data collection, including the data analysis process. This included training for enumerators, subjects and using a validated questionnaire for a group of subjects representing similar characteristics for this study. Data input and cleaning process will use excel and SPSS while for food intake data using NutriSurvey 2007. Data entry will be carried out by data collection officers after data collection. The data cleaning process includes removing outliers and regrouping multiple results that have similar meanings. The data will be interpreted as mean ± standard deviation if the data is normally distributed and the median (min-max) if the data is not normally distributed. Statistical analysis using SPSS 25 and data will be analyzed using univariate and bivariate analysis. Univariate analysis is used to describe characteristics and socio-demographics, medical history, pregnancy, and obstetric profiles of pregnant women. Numerical variables between groups will be analyzed using an Independent sample t-test if the data has normal distribution or the Mann Whitney test if the data distribution is not normal. Categorical variables between groups will be analyzed using Chi-square or Fisher test. Differences between birth and 3 months old follow up will be analyzed using independent t-tests if the data distribution has normal distribution or Mann Whitney test if the data distribution is not normal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Mothers with gestational 12 - 20 weeks

• Health Conditions

• Not moving home until delivery labour

• Not suffering from syndrome metabolic diseases

Exclusion Criteria:

• Not willing and signing an informed consent, and not willing to consume fungtional bread and dadih's vla or dadih sauce until delivery.

• Abortus

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Gestational Weight Gain
• Pregnancy Weight Gain
• Weight Gain

Intervention

Other:
• Bread and vla dadiah
Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.
• Bread and vla without dadiah
Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.

Locations

Country	Name	City	State
Indonesia	Universitas Andalas	Padang	West Sumatera

Sponsors (2)

Lead Sponsor	Collaborator
Andalas University	National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (24)

Arnold, M., Rajagukguk, Y.V. and Gramza-Michalowska, A., 2021. Characterization of Dadih: Traditional Fermented Buffalo Milk of Minangkabau. Beverages, 7(3), p.60.

Astuti, S.D., Andarwulan, N., Hariyadi, P. and Agustia, F.C., 2014. Formulasi dan karakterisasi cake berbasis tepung komposit organik kacang merah, kedelai, dan jagung. Jurnal Aplikasi Teknologi Pangan, 3(2).

Black, R.E. and Hopkins Bloomberg, J., 2008. The lancet series on maternal and child Undernutrition, executive summary. Lancet, 371, pp.1-10.

Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062 — View Citation

Caulfield, L.E., Huffman, S.L. and Piwoz, E.G., 1999. Interventions to improve intake of complementary foods by infants 6 to 12 months of age in developing countries: impact on growth and on the prevalence of malnutrition and potential contribution to chi

Collado MC, Surono IS, Meriluoto J, Salminen S. Potential probiotic characteristics of Lactobacillus and Enterococcus strains isolated from traditional dadih fermented milk against pathogen intestinal colonization. J Food Prot. 2007 Mar;70(3):700-5. doi: — View Citation

Dijkhuizen MA, Wieringa FT, West CE, Martuti S, Muhilal. Effects of iron and zinc supplementation in Indonesian infants on micronutrient status and growth. J Nutr. 2001 Nov;131(11):2860-5. doi: 10.1093/jn/131.11.2860. — View Citation

Efendi F, Chen CM, Kurniati A, Berliana SM. Determinants of utilization of antenatal care services among adolescent girls and young women in Indonesia. Women Health. 2017 May-Jun;57(5):614-629. doi: 10.1080/03630242.2016.1181136. Epub 2016 May 26. — View Citation

Fahmida U, Rumawas JS, Utomo B, Patmonodewo S, Schultink W. Zinc-iron, but not zinc-alone supplementation, increased linear growth of stunted infants with low haemoglobin. Asia Pac J Clin Nutr. 2007;16(2):301-9. — View Citation

Helmizar H, Jalal F, Lipoeto NI, Achadi EL. Local food supplementation and psychosocial stimulation improve linear growth and cognitive development among Indonesian infants aged 6 to 9 months. Asia Pac J Clin Nutr. 2017 Jan;26(1):97-103. doi: 10.6133/apjc — View Citation

Hess SY, Lonnerdal B, Hotz C, Rivera JA, Brown KH. Recent advances in knowledge of zinc nutrition and human health. Food Nutr Bull. 2009 Mar;30(1 Suppl):S5-11. doi: 10.1177/15648265090301S102. — View Citation

Hoj S, Fredholm M, Larsen NJ, Nielsen VH. Growth hormone gene polymorphism associated with selection for milk fat production in lines of cattle. Anim Genet. 1993 Apr;24(2):91-5. doi: 10.1111/j.1365-2052.1993.tb00246.x. — View Citation

Khotimah, K. and Kusnadi, J., 2014. Antibacterial Activity of Probiotic Dates (Phoenix dactilyfera L.) Using Lacbobacillus plantarum and Lacbobacillus casei. J. Pangan Agroind, 2(3), pp.110-120.

Lozupone CA, Stombaugh JI, Gordon JI, Jansson JK, Knight R. Diversity, stability and resilience of the human gut microbiota. Nature. 2012 Sep 13;489(7415):220-30. doi: 10.1038/nature11550. — View Citation

Ojofeitimi, E.O., Ogunjuyigbe, P.O., Sanusi, R.A., Orji, E.O., Akinlo, A., Liasu, S.A. and Owolabi, O.O., 2008. Poor dietary intake of energy and retinol among pregnant women: implications for pregnancy outcome in Southwest Nigeria. Pak. J. Nutr, 7(3), pp

Shah, N.P., 2006. Health benefits of yogurt and fermented milks. Manufacturing yogurt and fermented milks, 327.

Surono IS, Martono PD, Kameo S, Suradji EW, Koyama H. Effect of probiotic L. plantarum IS-10506 and zinc supplementation on humoral immune response and zinc status of Indonesian pre-school children. J Trace Elem Med Biol. 2014 Oct;28(4):465-9. doi: 10.101 — View Citation

Surono IS. Traditional Indonesian dairy foods. Asia Pac J Clin Nutr. 2015;24 Suppl 1:S26-30. doi: 10.6133/apjcn.2015.24.s1.05. — View Citation

Unayah, A., Estuti, W., Kunaepah, U., Studies, N., Tasikmalaya, P.K. and Barat, J., 2020. Use of Local Food Ingredients MOCAF (Modified Cassava Flour) and Rebon Planktonic Shrimp) in Cookies as an Alternative Supplementary Food for Children. International

UNICEF. Division of Communication and UNICEF., 2009. Tracking progress on child and maternal nutrition: a survival and development priority. Unicef.

Wijayanti, IA, Purwadi, P., & Thohari, I. (2017). The Effect of Adding Sago Flour to Yoghurt on the Physical Properties of Yoghurt Ice Cream. Journal of Animal Products Science and Technology (JITEK), 11(1), 38-45.

Wijayanti, MDS, Thohari, I., & Purwadi, P. 2017. Quality of curd in goat's milk incubated on various kinds of bamboo. Journal of Animal Products Science and Technology (JITEK), 11(1), 22-37.

Yarandi SS, Peterson DA, Treisman GJ, Moran TH, Pasricha PJ. Modulatory Effects of Gut Microbiota on the Central Nervous System: How Gut Could Play a Role in Neuropsychiatric Health and Diseases. J Neurogastroenterol Motil. 2016 Apr 30;22(2):201-12. doi: — View Citation

Young Child Nutrition Working Group: Formulation Subgroup. Formulations for fortified complementary foods and supplements: review of successful products for improving the nutritional status of infants and young children. Food Nutr Bull. 2009 Jun;30(2 Supp — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Pregnant Woman Measurement	Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)	12 weeks
Primary	Body Height Pregnant Woman Measurement	Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)	12 weeks
Primary	Body Mass Index Pregnant Woman Measurement	Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)	12 weeks
Primary	Birth Weight of Infant Measurement	Measuring weight of infant (Weight in Grams)	9 months
Primary	Birth Length of Infant Measurement	Measuring Birth Length of infant (Length or height in Centimeters)	9 months
Secondary	Characteristic of Woman Pregnancy	Description of Characteristic respondent are Mother's tribe, mother's education, mother's job, mother's knowledge, family income, age, and gestational weeks	4 weeks

External Links

•   Antibacterial Activity of Probiotic Dates (Phoenix dactilyfera L.) Using Lacbobacillus plantarum and Lacbobacillus casei. J. Pangan Agroind, 2(3), pp.110-120.
•   Characterization of Dadih: Traditional Fermented Buffalo Milk of Minangkabau. Beverages, 7(3), p.60.
•   Determinants of utilization of antenatal care services among adolescent girls and young women in Indonesia. Women & health, 57(5), pp.614-629.
•   Diversity, stability and resilience of the human gut microbiota. Nature, 489(7415), pp.220-230.
•   Effect of probiotic L. plantarum IS-10506 and zinc supplementation on humoral immune response and zinc status of Indonesian pre-school children. Journal of Trace Elements in Medic
•   Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062
•   Effects of iron and zinc supplementation in Indonesian infants on micronutrient status and growth. The Journal of nutrition, 131(11), pp.2860-2865.
•   Health benefits of yogurt and fermented milks. Manufacturing yogurt and fermented milks, 327.
•   Local food supplementation and psychosocial stimulation improve linear growth and cognitive development among Indonesian infants aged 6 to 9 months. Asia Pacific journal of clinical nutrition,
•   Modulatory effects of gut microbiota on the central nervous system: how gut could play a role in neuropsychiatric health and diseases. Journal of neurogastroenterology an
•   Potential probiotic characteristics of Lactobacillus and Enterococcus strains isolated from traditional dadih fermented milk against pathogen intestinal colonization. J Food Prot. 2007 Mar;70(3):700-5. doi:
•   The lancet series on maternal and child Undernutrition, executive summary. Lancet, 371, pp.1-10.
•   Tracking progress on child and maternal nutrition: a survival and development priority. Unicef.
•   Traditional Indonesian dairy foods. Asia Pac J Clin Nutr 2015;24 (suppl 1):S26-S30. Doi: 10.6133/apjcn
•   Use of Local Food Ingredients MOCAF (Modified Cassava Flour) and Rebon Planktonic Shrimp) in Cookies as an Alternative Supplementary Food for Children. International
•   Zinc-iron, but not zinc-alone supplementation, increased linear growth of stunted infants with low haemoglobin. Asia Pacific Journal of Clinical Nutrition, 16(2), pp.301-309.