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The Effects of Structured Lactation Nutrition Education and Dali ni Horbo Supplementation on Maternal Nutritional Intake, Breastfeeding Practices, Infant Growth, and Gut Microbiota: A Randomized Controlled Trial

The Effects of Structured Lactation Nutrition Education and Dali ni Horbo Supplementation on Maternal Nutritional Intake, Breastfeeding Practices, Infant Growth, and Gut Microbiota: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07718087
Enrollment
50
Registered
2026-07-21
Start date
2026-08-01
Completion date
2026-10-31
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternity Care, Nutrition Education

Keywords

Lactation nutrition, Dali ni Horbo, Exclusive breastfeeding, Infant growth, Infant gut microbiota

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTDali ni Horbo Supplementation

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.

OTHERStandard Maternal Care

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.

Sponsors

DINA KEUMALA SARI
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Lactating mothers aged 18-40 years. * Having a healthy, singleton infant aged 0-1 month at enrollment. * Residing within the service areas of the participating primary healthcare centers in Medan, Indonesia. * Currently breastfeeding and intending to continue breastfeeding throughout the study period. * Able to consume Dali ni Horbo and willing to follow the assigned intervention. * Willing to participate in all study assessments, including dietary assessment, anthropometric measurements, and infant stool collection. * Able to communicate effectively and complete the study questionnaires. * Willing to provide written informed consent.

Exclusion criteria

* Mothers or infants with medical conditions that may significantly affect breastfeeding, maternal nutritional status, nutrient metabolism, or infant growth. * Mothers with severe postpartum complications or conditions requiring hospitalization. * Infants with congenital abnormalities, gastrointestinal disorders, metabolic diseases, severe infections, or other conditions affecting feeding or growth. * Infants born preterm or with low birth weight, according to the study protocol. * Mothers with a known allergy or intolerance to buffalo milk, cow's milk, or dairy products. * Mothers following a medically prescribed restrictive diet that could affect the study outcomes. * Current participation in another nutritional or clinical intervention study. * Use of nutritional supplements, probiotics, antibiotics, or other treatments that may substantially affect maternal nutrient intake or infant gut microbiota, unless permitted by the study protocol. * Inability or unwillingness to comply with the intervention and follow-up procedures.

Design outcomes

Primary

MeasureTime frameDescription
Change in Maternal Energy and Nutrient Intakebaseline and 4 weeksChange 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.

Countries

Indonesia

Contacts

CONTACTAnggi Yosefin Pratiwi Butar Butar
anggiyosefin@gmail.com+6281362419458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026