CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
DHA Wet Mixing method +2 moredietary
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04460287
NCT04460287N/ACompleted

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

Indonesian Nutrition Association·interventional·Posted Jul 7, 2020·Updated Apr 16, 2025

In Brief

A clinical study evaluating DHA Wet Mixing method, DHA Dry Blending Method, and 1 other intervention for Healthy Children. Completed, enrolled 91 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 7, 2020
Enrollment StartFeb 17, 2023
Primary CompletionMar 1, 2024
Study CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.0 years ago

Interventions

DHA Wet Mixing methoddietary

Children will drink milk contain 100 mg DHA wet mixing daily for 30 days

DHA Dry Blending Methoddietary

Children will drink milk contain 100 mg DHA dry blending daily for 30 days

Fish Oildietary

Children will have this intervention every day for 30 days