NCT05712629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

January 3, 2023

Last Update Submit

February 4, 2023

Conditions

Birth WeightPregnancy Weight Gain

Keywords

Functional BreadWeight IncreaseInfant Weight

Outcome Measures

Primary Outcomes (5)

  • Body Weight Pregnant Woman Measurement

    Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)

    12 weeks

  • 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

  • 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

  • Birth Weight of Infant Measurement

    Measuring weight of infant (Weight in Grams)

    9 months

  • Birth Length of Infant Measurement

    Measuring Birth Length of infant (Length or height in Centimeters)

    9 months

Secondary Outcomes (1)

  • Characteristic of Woman Pregnancy

    4 weeks

Study Arms (2)

Responden Intervention

ACTIVE COMPARATOR

Arm 1 (Interventional) : Respondent has given bread with composit flour and vla with dadiah. pregnant women received 1 pieces bread containing 50 gram provide total fat 4 gram, protein 5 gram, carbohydrate 23.8 gram, Fe 2 mg, 2150 kcal and vla dadiah containing 30 gram provide 308 kcal.

Other: Bread and vla dadiah

Responden Placebo

PLACEBO COMPARATOR

Arm 2 (Placebo) : Respondent has given bread with original flour (wheat flour) and vla original without dadiah. pregnant women received 1 pieces bread containing 50 gram and vla containing 30 gram.

Other: Bread and vla without dadiah

Interventions

Bread and vla dadiahOTHER

Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.

Responden Intervention
Bread and vla without dadiahOTHER

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

Responden Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers with gestational 12 - 20 weeks
  • Health Conditions
  • Not moving home until delivery labour
  • Not suffering from syndrome metabolic diseases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Andalas

Padang, West Sumatera, 25127, Indonesia

Location

Related Publications (24)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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).

    RESULT

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

    RESULT

  • 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.

    PMID: 12036814RESULT

  • 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: 10.4315/0362-028x-70.3.700.

    PMID: 17388062RESULT

  • 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 child survival. Food and nutrition bulletin, 20(2), pp.183-200.

    RESULT

  • 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 Suppl):S239-55. No abstract available.

    PMID: 20496618RESULT

  • 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.

    PMID: 11694609RESULT

  • 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.

    PMID: 17468087RESULT

  • 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/apjcn.102015.10.

    PMID: 28049268RESULT

  • 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.

    PMID: 19472599RESULT

  • 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.

    PMID: 7687103RESULT

  • 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.

    RESULT

  • 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.

    PMID: 27230132RESULT

  • 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.

    PMID: 22972295RESULT

  • 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.480-484.

    RESULT

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

    RESULT

  • 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 Journal of Innovation, Creativity and Change, pp.1035-1050.

    RESULT

  • 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.

    PMID: 26715081RESULT

  • 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: 10.1016/j.jtemb.2014.07.009. Epub 2014 Aug 2.

    PMID: 25183688RESULT

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

    RESULT

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

    RESULT

  • 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: 10.5056/jnm15146.

    PMID: 27032544RESULT

Related Links

MeSH Terms

Conditions

Birth WeightGestational Weight GainWeight Gain

Interventions

Bread

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Helmizar Helmizar, DR

    Nutrition Department Faculty of Universitas Andalas

    PRINCIPAL INVESTIGATOR

  • Azrimaidaliza Azrimaidaliza, DR

    Department Nutrition Faculty of Universitas Andalas

    STUDY DIRECTOR

  • Ferdinal Ferry, DR

    Department Obstetry and Gynecology of Universitas Andalas

    STUDY DIRECTOR

  • Frima Elda, DR

    Department Nutrition Faculty of Universitas Andalas

    STUDY DIRECTOR

  • Asrawati Asrawati, DR

    Department Pediatric of Universitas Andalas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Helmizar, SKM, M.Biomed

Study Record Dates

First Submitted

January 3, 2023

First Posted

February 3, 2023

Study Start

April 12, 2022

Primary Completion

September 20, 2022

Study Completion

December 20, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)