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

September 26, 2023 updated by: Indonesian Nutrition Association

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will use two phase approaches Phase 1, screening habitual n3 intake. Mothers of healthy toddlers, non-fish or non-n3 supplement babies (aged 2-3 years old) would be invited to complete a Food Frequency Questionnaire (FFQ) to determine their habitual dietary intake of long chain n3 fatty acids. The 120 babies with the lowest long chain n3 intake would be invited to proceed to phase 2 of the trial.

Phase 2, double blinded, randomized trial. Based on the outcome of the FFQ in phase 1 of the proposed trial, the 120 babies with the lowest habitual dietary intake will be allocated to diet in a random order for one month. Blood samples will be collected via dry blood spot kits at the start, middle and end of the diet along with faecal collection every day.

Groups are Milk drink unfortified (negative control), Milk drink unfortified plus fish oil (positive control), Milk drink fortified with DHA used wet mixing method and Milk drink fortified with DHA used dry blending method.

Population and subjects are Indonesian children aged 2-3 years old living in Jakarta will be selected if they meet the study criteria.

For stage-1: to get 50% of children having habitual low DHA intake, with degree of significance 5% and degree of reliability 95%, then 385 children will be needed.

For stage-2: This study will include 30 subjects per-study group

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Boys and girls aged 2-3 years old, apparently healthy, living in the study area for minimally one month and parents permit them to participate in the study by signing the informed consent.

Exclusion Criteria:

  • Having milk allergy and/or lactose intolerance, high omega-3 intake habit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Milk Drink Unfortified (Negative Control)
Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days.
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
Other Names:
  • Children will have milk drink and Fish Oil contain 100 mg/DHA daily for 30 days
Active Comparator: Milk Drink Unfortified Plus Fish Oil (Positive Control)
Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days
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
Experimental: Milk Drink Fortified with DHA Used Wet Mixing Method
Children will get the product (packed for its individual portion) that must be consumed once a day 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
Other Names:
  • Children will have milk drink and Fish Oil contain 100 mg/DHA daily for 30 days
Experimental: Milk Drink Fortified with DHA Used Dry Blending Method
Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days
Dietary supplement: DHA Wet Mixing method
Children will drink milk contain 100 mg DHA wet mixing daily for 30 days
Dietary supplement: Fish Oil
Children will have this intervention every day for 30 days
Other Names:
  • Children will have milk drink and Fish Oil contain 100 mg/DHA daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DHA level in RBC lipid and faecal
Time Frame: One month
Blood and faecal specimen
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesian Nutrition Association

Investigators

  • Principal Investigator: Diana Sunardi, Doctor, Faculty of Medicine University of Indonesia Cipto Mangunkusumo Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • INA/NM-20010028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Children

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe