Effects of oral nutrition supplement on the nutritional status of infants aged 6–12 months
| ISRCTN | ISRCTN13402097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13402097 |
| Sponsor | Nestlé Philippines Inc. |
| Funder | Nestlé Philippines Inc. |
- Submission date
- 21/04/2026
- Registration date
- 27/04/2026
- Last edited
- 23/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The first year of life is a critical time for growth and development. From six months of age, infants need foods in addition to breast milk to meet their increasing nutritional needs. In some communities, infants may not receive enough variety and nutrients from their diet, which can affect their growth and health. This study aims to find out whether giving an oral nutritional supplement in the form of fortified infant cereal, with or without nutrition education for parents or caregivers, can help support healthy growth in infants.
Who can participate?
Infants aged 6 to 8 months with normal weight for their age can take part in the study. Participants must live in selected communities in Cagayan de Oro City, Philippines. Parents/caregivers must be willing to give consent and take part in study activities. Both male and female infants can participate.
What does the study involve?
Participants are placed into one of three groups by chance (randomly):
• Infants who receive an oral nutritional supplement and whose parents/caregivers attend nutrition education sessions
• Infants who receive an oral nutritional supplement only
• Infants who continue with their usual diet and do not receive the oral nutritional supplement
The study lasts for four months or 120 days. Infants in the intervention (oral nutrition supplement: fortified infant cereal) groups are given one serving of the food supplement each day. Feeding is supervised during weekdays at a community site, and oral nutritional supplement is provided for home use during weekends.
Parents/caregivers in the nutrition education group attend a total of eight sessions on infant feeding and nutrition, conducted twice a month.
Researchers measure the infants’ growth (weight, length, and mid-upper arm circumference) and collect information about their food intake and developmental milestones at baseline, midline, and endline of the study.
What are the possible benefits and risks of participating?
Participants may benefit from improved nutrition and regular monitoring of their child’s growth and health. Parents/caregivers may also gain useful knowledge about proper infant feeding.
The risks are low. Some infants may experience mild digestive discomfort when trying new foods. Any health concerns are closely monitored, and appropriate care is provided if needed.
Where is the study run from?
The study is managed by the research team and conducted in selected barangays (Lapasan, Canitoan, Bulua, and Patag) in Cagayan de Oro City, Philippines.
When is the study starting and how long is it expected to run for?
Participant enrollment started in April 2, 2025 and ended in April 25, 2025. Each participant takes part in the study for about four months.
Who is funding the study?
Nestlé Philippines Inc.
Who is the main contact?
Principal Investigator: Imelda Angeles-Agdeppa, Ph.D.
Email: iangelesagdeppa@yahoo.com.ph
Contact information
Principal investigator, Scientific, Public
Unit 1105, The Centerpoint Building, Julia Vargas Avenue corner Garnet Street, Ortigas Center
Pasig
1605
Philippines
 ORCID ID |
0000-0001-9132-7399 |
|---|---|
| Phone | +63 9175460189 |
| iangelesagdeppa@yahoo.com.ph |
Public, Scientific
Unit 1105, The Centerpoint Building, Julia Vargas Avenue corner Garnet Street, Ortigas Center
Pasig
1605
Philippines
| ORCID ID |
0000-0003-3595-0535 |
|---|---|
| Phone | +63 9674606618 |
| zjezreelann@gmail.com; j.zamora@gipdex.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Effects of consuming oral nutrition supplement on the nutritional status of infants aged 6–12 months: a randomized parallel-group trial |
| Study objectives | To determine the effect of oral nutrition supplementation (ONS) in the form of fortified infant cereal, with or without nutrition education (NE), on the maintenance of normal weight-for-age among infants aged 6 to 12 months, measured as change in body weight from baseline to endline. |
| Ethics approval(s) |
Approved 26/02/2025, Asian Hospital and Medical Center Research Ethics Committee (Research Ethics Committee Office, 7th Floor, Tower 2, Asian Hospital and Medical Center, 2205 Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa, 1780, Philippines; +63 8771-9000 local 8163; acabardo@asianhospital.com), ref: 2024-041 |
| Health condition(s) or problem(s) studied | Nutritional status of infants aged 6–12 months |
| Intervention | This study uses a randomized, parallel-group controlled design involving infants aged 6 to 12 months with normal weight-for-age at baseline. A total of 195 participants are enrolled and randomly assigned into three groups (n=65 per group) using stratified randomization by sex and study site. The intervention consists of oral nutrition supplementation (ONS) in the form of fortified infant cereal, with or without nutrition education (NE), administered over a 120-day period. The study includes the following groups: (1) ONS combined with NE, (2) ONS alone, and (3) control group receiving no intervention and continuing their usual dietary intake. Participants in the intervention groups receive ONS in the form of fortified infant cereal (40 g sachet mixed with 120 mL distilled water), consumed once daily under supervised feeding from Monday to Friday at a community site, with take-home rations provided for weekend consumption. The ONS is administered in four infant cereal variants (mixed vegetables and soya, wheat banana and milk, rice and soya, and mixed fruits and soya), given alternately. The NE intervention is delivered to parents/caregivers in the ONS+NE group through eight structured sessions conducted twice monthly, focusing on infant and young child feeding practices. Anthropometric measurements (weight, length, and mid-upper arm circumference) are collected at baseline, monthly, and endline using standardized procedures. Dietary intake is assessed using two non-consecutive 24-hour food recalls at baseline, midline, and endline, supplemented by weekly food diary records. Additional data collected include developmental milestones, gastrointestinal tolerance, nutrition knowledge, and acceptability of the ONS. The study incorporates elements of an open-label design, as participants and selected Local Researchers (LRs) involved in intervention delivery and data validation are aware of group allocation. However, blinding is maintained among key study personnel, including LRs responsible for data collection, the database manager, the statistician, and the principal investigator, who remain blinded to group allocation until completion of data analysis to minimize bias and ensure objectivity. In addition, participants are not informed of the brand of the oral nutrition supplement (ONS), providing a degree of masking. The primary outcome is change in body weight from baseline to endline, used to assess maintenance of normal weight-for-age status across groups. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/08/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 8 Months |
| Sex | All |
| Target sample size at registration | 195 |
| Total final enrolment | 195 |
| Key inclusion criteria | 1. Infants aged 6 months to 8 months at baseline with normal weight for age defined as between minus 2 and plus 2 weight for age z scores according to the WHO Child Growth Standards 2. No known allergy to wheat, soya or cow’s milk 3. Not suffering from diarrhoea, respiratory infection or fever at baseline 4. Not currently participating in any complementary feeding programme 5. Not planning to move residence for the duration of the intervention 6. Written informed consent signed by a parent or legal guardian 7. Parents or caregivers willing to participate in nutrition education class activities 8. Infant parent or legal guardian is of the legal age of majority, able to understand the informed consent form and other relevant study documents, and willing and able to comply with the study protocol 9. Existing breastfeeding and or milk feeding practices will not be altered by the study. Feeding practices will be recorded and accounted for in the analysis as potential confounding variables. Infants with normal weight will be eligible regardless of feeding practices |
| Key exclusion criteria | 1. Undergoing treatment on any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at baseline 2. Participant in an on-going complementary feeding program 3. With allergy on wheat, soya, cow’s milk 4. With physical disability that affects normal feeding of infants e.g. cleft lip or palate 5. Parents/caregivers who are not willing to participate in the feeding and NE class activities 6. Without signed parental ICF 7. Overweight, obese, undernourished 8. Low-birth-weight (LBW) or premature baby 9. Children identified with moderate acute malnutrition (MAM) or severe acute malnutrition (SAM) will be referred to the nearest health facility for appropriate management |
| Date of first enrolment | 02/04/2025 |
| Date of final enrolment | 25/04/2025 |
Locations
Countries of recruitment
- Philippines
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
21/04/2026: Trial's existence confirmed by Asian Hospital and Medical Center Research Ethics Committee.
