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

NCT07718087 | Not Yet Recruiting DMC

• 1 other identifier: USU Maternity Nutrition
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternity Care; Nutrition Education

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 4 weeks

Study Arms (2)

experimental: Dali ni Horbo 100g/day

EXPERIMENTAL

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

control group

OTHER

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

Interventions

Dali ni Horbo Supplementation DIETARY_SUPPLEMENT

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.

experimental: Dali ni Horbo 100g/day

Standard Maternal Care OTHER

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.

control group; experimental: Dali ni Horbo 100g/day

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DINA KEUMALA SARI: lead

Study Sites (1)

Nutrition Departement, Universitas Sumatera Utara, Medan, Indonesia

Medan, North Sumatera, Indonesia

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Anggi Yosefin Pratiwi Butar Butar

CONTACT

+6281362419458; anggiyosefin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

ID (1)