NCT04460287

Bioavailability of Different Formulas Enriched With DHA Using Wet Mixing or Dry Blending Method

Completed NA Last updated 16 April 2025

What this trial tests

NA trial testing DHA Wet Mixing method in Healthy Children in 91 participants. Completed in 30 May 2024.

Timeline

17 February 2023

Primary endpoint
1 March 2024

30 May 2024

Quick facts

Lead sponsor	Indonesian Nutrition Association
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	91
Start date	17 February 2023
Primary completion	1 March 2024
Estimated completion	30 May 2024
Sites	1 location across Indonesia

Drugs / interventions tested

• DHA Wet Mixing method
• DHA Dry Blending Method
• Fish Oil — full drug profile →

Conditions studied

• Healthy Children — all drugs for Healthy Children →

Sponsor

Indonesian Nutrition Association

Who can join

Adults 2 to 3, any sex, with Healthy Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infants and young children have high nutritional demands in order to support adequate growth and development, particularly during the transition from complementary feeding at 12 months of age to a mixed and varied diet at 36 months of age. Omega-3 long chain polyunsaturated fatty acid (n-3 LC-PUFA) such as docosahexaenoic acid (DHA; 22:6n-3) is the important constituents of the maturing brain, especially for visual and cognitive development. However only certain foods, such as fatty fish, contain n-3 LC-PUFA at concentrations sufficient for their needs. Additionally, these foods that are known to be rich in DHA may not be regularly provided to infants and toddlers due to concerns about potential food allergies or methylmercury exposure.

Although the importance of consuming n-3 LC-PUFA and essential fatty acids at the level of dietary recommendations in late infancy and early childhood (6-24 months) are highlighted, the current median n-3 LC-PUFA and estimated DHA intakes in toddlers in most countries are lower than the recommended levels. The European Food Safety Authority (EFSA) recommend that infants and young children (\< 24 months) should consume 100 mg of DHA per day, while for older children (2-18 years), they recommend a daily intake of 250 mg. In order to bridge the gap between the current intake and recommended levels of n-3 LC-PUFA, general foods, especially infant and toddler formulas, should be enriched with n-3 LC-PUFA particularly DHA. With a growing body of research, the challenge is to find an ideal formula that is nutritionally balanced and human milk-like, especially with respect to the ratio between omega-6 and omega-3 fatty acids and DHA level.

In adding DHA into the toddler formula, there are several methods, among others are in the form of wet mix and dry blending. The aim of this study is to compare the bioavailability of different methods of adding DHA (dry blend versus wet mix) into formulas in healthy Indonesian toddlers age 2-3 years old for a period of one month. Furthermore, to evaluate the stability of milk-based formulas that are supplemented with DHA under same storage conditions, so as to monitor the stability of infant formula.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tuna Oil-Enriched Toddler Formula Enhances DHA Status in Indonesian Toddlers.
   Sunardi D, Fard SG, Ratih MP, Herawati A, et al · · 2025 · PMID 40918177 · DOI 10.1002/fsn3.70838