An interventional study of Dali ni Horbo Supplementation and Standard Maternal Care in Maternity Care and Nutrition Education, sponsored by DINA KEUMALA SARI. Not yet recruiting at 1 site in Indonesia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by DINA KEUMALA SARI · Not applicable, Interventional, and Supportive care
This randomized controlled trial aims to evaluate the effects of structured lactation nutrition education combined with Dali ni Horbo supplementation on maternal dietary intake, breastfeeding practices, infant growth, and infant gut microbiota. Lactating mothers with healthy infants aged 0-1 month will be recruited from selected primary healthcare centers in Medan, Indonesia, and assigned to an intervention or control group. The intervention group will receive structured nutrition education and daily Dali ni Horbo, a traditional Batak fermented buffalo milk product, while the control group will receive standard care. Maternal energy and nutrient intake, nutritional knowledge and attitudes, exclusive breastfeeding practices, maternal and infant anthropometric measurements, intervention adherence, adverse effects, and infant fecal microbiota composition will be assessed before and after the intervention. This study is expected to determine whether integrating nutrition education with a nutrient-dense local food can improve maternal nutritional adequacy, support exclusive breastfeeding, promote optimal infant growth, and beneficially influence early-life gut microbiota.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →DINA KEUMALA SARI is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention consists of daily supplementation with Dali ni Horbo, a traditional Batak food made from coagulated buffalo milk, provided to lactating mothers in a standardized portion throughout the study period. The product is intended to increase maternal energy, protein, fat, calcium, and other nutrient intake during lactation. Participants will receive instructions on the amount, timing, storage, and consumption of the product. Adherence will be monitored through daily records and regular interviews, while gastrointestinal complaints, intolerance, or other adverse effects will also be documented.
Dietary Supplement: Dali ni Horbo Supplementation · Other: Standard Maternal Care
Participants in the control group will receive standard maternal and child healthcare services routinely provided at the participating primary healthcare centers, without Dali ni Horbo supplementation. They will continue their usual diet and breastfeeding practices throughout the study period. Maternal dietary intake, breastfeeding practices, nutritional status, infant growth, and infant gut microbiota will be assessed using the same schedule and methods as in the intervention group. Any additional nutritional supplements or relevant dietary changes during the study will be recorded.
Other: Standard Maternal Care
Participants will receive structured lactation nutrition education delivered by trained nutritionists according to a standardized educational protocol, together with daily supplementation of Dali ni Horbo, a traditional Batak coagulated buffalo milk product, throughout the intervention period. The education focuses on balanced nutrition during lactation, adequate energy and nutrient intake, hydration, food diversity, and breastfeeding practices. Dali ni Horbo will be provided in standardized daily portions, and participants will receive instructions regarding its consumption, storage, and handling. Adherence and any adverse events will be monitored throughout the study.
Participants will receive routine maternal and child healthcare services provided at the participating primary healthcare centers, including standard postpartum and breastfeeding counseling according to local practice, without structured lactation nutrition education or Dali ni Horbo supplementation. Participants will continue their usual diet and breastfeeding practices throughout the study period and will undergo the same outcome assessments as the intervention group.
Change in Maternal Energy and Nutrient Intake
Change in maternal dietary intake from baseline to the end of the intervention, assessed using 24-hour dietary recalls and analyzed for daily energy, protein, fat, carbohydrate, and calcium intake. Nutrient intake will be compared between the intervention and control groups to evaluate the effectiveness of structured lactation nutrition education combined with Dali ni Horbo supplementation.
Time frame: baseline and 4 weeks
Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 1 month is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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DINA KEUMALA SARI