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

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.

Conditions

• Healthy Children

Interventions

DIETARY_SUPPLEMENT

DHA Wet Mixing method

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

DIETARY_SUPPLEMENT

DHA Dry Blending Method

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

DIETARY_SUPPLEMENT

Fish Oil

Children will have this intervention every day for 30 days

Sponsors & Collaborators

• Indonesian Nutrition Association

  lead OTHER

Principal Investigators

• Diana Sunardi, Doctor · Faculty of Medicine University of Indonesia Cipto Mangunkusumo Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

3 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-17

Primary Completion

2024-03-01

Completion

2024-05-30

Countries

• Indonesia

Study Locations