Healthy ChildrenNCT04460287
Bioavailability of Different Formulas Enriched With DHA Using Wet Mixing or Dry Blending Method
A study testing DHA Wet Mixing method, DHA Dry Blending Method and Fish Oil in people with Healthy Children, run by Indonesian Nutrition Association at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- DHA Wet Mixing method, DHA Dry Blending Method and Fish Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Feb 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Having milk allergy and/or lactose intolerance, high omega-3 intake habit
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Sekretariat RW 12 Cipinang besar
Jakarta, DKI Jakarta, 13410
About this study
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.
Read the 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
- Conditions
- Healthy Children
- Being tested
- DHA Wet Mixing method, DHA Dry Blending Method, Fish Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA Wet Mixing methodDietary supplement
Children will drink milk contain 100 mg DHA wet mixing daily for 30 days
DHA Dry Blending MethodDietary supplement
Children will drink milk contain 100 mg DHA dry blending daily for 30 days
Fish OilDietary supplement
Also called Children will have milk drink and Fish Oil contain 100 mg/DHA daily for 30 days
Children will have this intervention every day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Milk Drink Unfortified (Negative Control) | Placebo comparator | Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days. Receives: Dietary Supplement: DHA Wet Mixing method; Dietary Supplement: DHA Dry Blending Method; Dietary Supplement: Fish Oil |
| Milk Drink Unfortified Plus Fish Oil (Positive Control) | Active comparator | Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days Receives: Dietary Supplement: DHA Wet Mixing method; Dietary Supplement: DHA Dry Blending Method |
| Milk Drink Fortified with DHA Used Wet Mixing Method | Experimental | Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days Receives: Dietary Supplement: DHA Dry Blending Method; Dietary Supplement: Fish Oil |
| Milk Drink Fortified with DHA Used Dry Blending Method | Experimental | Children will get the product (packed for its individual portion) that must be consumed once a day for 30 days Receives: Dietary Supplement: DHA Wet Mixing method; Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHA level in RBC lipid and faecal
Blood and faecal specimen
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start17 Feb 2023
- Primary completion1 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indonesian Nutrition Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Sunardi, Doctor, Principal investigator, Faculty of Medicine University of Indonesia Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460287
- Sponsor's protocol ID
- INA/NM-20010028
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2020
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keim SA, Branum AM. Dietary intake of polyunsaturated fatty acids and fish among US children 12-60 months of age. Matern Child Nutr. 2015 Oct;11(4):987-98. doi: 10.1111/mcn.12077. Epub 2013 Sep 13.
PubMed 24034437Osendarp, S.J., The role of omega-3 fatty acids in child development. Oléagineux, Corps gras, Lipides, 2011. 18(6): p. 307-313
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of a health claim related to DHA and contribution to normal brain development pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA J. 2014 Oct 8;12(10):3840. doi: 10.2903/j.efsa.2014.3840. eCollection 2014 Oct.
PubMed 42087978Meyer BJ, Mann NJ, Lewis JL, Milligan GC, Sinclair AJ, Howe PR. Dietary intakes and food sources of omega-6 and omega-3 polyunsaturated fatty acids. Lipids. 2003 Apr;38(4):391-8. doi: 10.1007/s11745-003-1074-0.
PubMed 12848284Innis SM, Vaghri Z, King DJ. n-6 Docosapentaenoic acid is not a predictor of low docosahexaenoic acid status in Canadian preschool children. Am J Clin Nutr. 2004 Sep;80(3):768-73. doi: 10.1093/ajcn/80.3.768.
PubMed 15321820Barbarich BN, Willows ND, Wang L, Clandinin MT. Polyunsaturated fatty acids and anthropometric indices of children in rural China. Eur J Clin Nutr. 2006 Sep;60(9):1100-7. doi: 10.1038/sj.ejcn.1602424. Epub 2006 Mar 15.
PubMed 16538238Kim Y, Kim H, Kwon O. Dietary intake of n-3 and n-6 polyunsaturated fatty acids in Korean toddlers 12-24 months of age with comparison to the dietary recommendations. Nutr Res Pract. 2019 Aug;13(4):344-351. doi: 10.4162/nrp.2019.13.4.344. Epub 2019 Jul 24.
PubMed 31388411Tsuboyama-Kasaoka N, Takizawa A, Tsubota-Utsugi M, Nakade M, Imai E, Kondo A, Yoshida K, Okuda N, Nishi N, Takimoto H. Dietary intake of nutrients with adequate intake values in the dietary reference intakes for Japanese. J Nutr Sci Vitaminol (Tokyo). 2013;59(6):584-95. doi: 10.3177/jnsv.59.584.
PubMed 24477258Gibson, S. and A. Sidnell, Nutrient adequacy and imbalance among young children aged 1-3 years in the UK. Nutrition bulletin, 2014. 39(2): p. 172-180
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Different Formulas Enriched With DHA Using Wet Mixing or Dry Blending Method
- ClinicalTrials.gov ID
- NCT04460287
- Acronym / sponsor ID
- INA/NM-20010028
- Conditions
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Indonesian Nutrition AssociationUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk Drink Unfortified (Negative Control) | Placebo comparator | Dietary Supplement: DHA Wet Mixing method, Dietary Supplement: DHA Dry Blending Method, Dietary Supplement: Fish OilChildren will get the product (packed for its individual portion) that must be consumed once a day for 30 days. |
| Milk Drink Unfortified Plus Fish Oil (Positive Control) | Active comparator | Dietary Supplement: DHA Wet Mixing method, Dietary Supplement: DHA Dry Blending MethodChildren will get the product (packed for its individual portion) that must be consumed once a day for 30 days |
| Milk Drink Fortified with DHA Used Wet Mixing Method | Experimental | Dietary Supplement: DHA Dry Blending Method, Dietary Supplement: Fish OilChildren will get the product (packed for its individual portion) that must be consumed once a day for 30 days |
| Milk Drink Fortified with DHA Used Dry Blending Method | Experimental | Dietary Supplement: DHA Wet Mixing method, Dietary Supplement: Fish OilChildren will get the product (packed for its individual portion) that must be consumed once a day for 30 days |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Having milk allergy and/or lactose intolerance, high omega-3 intake habit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA Wet Mixing methodChildren will drink milk contain 100 mg DHA wet mixing daily for 30 days | Dietary supplement | Milk Drink Fortified with DHA Used Dry Blending Method, Milk Drink Unfortified (Negative Control), Milk Drink Unfortified Plus Fish Oil (Positive Control) |
| DHA Dry Blending MethodChildren will drink milk contain 100 mg DHA dry blending daily for 30 days | Dietary supplement | Milk Drink Fortified with DHA Used Wet Mixing Method, Milk Drink Unfortified (Negative Control), Milk Drink Unfortified Plus Fish Oil (Positive Control) |
| Fish OilAlso: Children will have milk drink and Fish Oil contain 100 mg/DHA daily for 30 daysChildren will have this intervention every day for 30 days | Dietary supplement | Milk Drink Fortified with DHA Used Dry Blending Method, Milk Drink Fortified with DHA Used Wet Mixing Method, Milk Drink Unfortified (Negative Control) |
Primary outcome
DHA level in RBC lipid and faecal
Time frame: One month
Blood and faecal specimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 24034437Keim SA, Branum AM. Dietary intake of polyunsaturated fatty acids and fish among US children 12-60 months of age. Matern Child Nutr. 2015 Oct;11(4):987-98. doi: 10.1111/mcn.12077. Epub 2013 Sep 13.
- BackgroundOsendarp, S.J., The role of omega-3 fatty acids in child development. Oléagineux, Corps gras, Lipides, 2011. 18(6): p. 307-313
- Background: PubMed 42087978EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of a health claim related to DHA and contribution to normal brain development pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA J. 2014 Oct 8;12(10):3840. doi: 10.2903/j.efsa.2014.3840. eCollection 2014 Oct.
- Background: PubMed 12848284Meyer BJ, Mann NJ, Lewis JL, Milligan GC, Sinclair AJ, Howe PR. Dietary intakes and food sources of omega-6 and omega-3 polyunsaturated fatty acids. Lipids. 2003 Apr;38(4):391-8. doi: 10.1007/s11745-003-1074-0.
- Background: PubMed 15321820Innis SM, Vaghri Z, King DJ. n-6 Docosapentaenoic acid is not a predictor of low docosahexaenoic acid status in Canadian preschool children. Am J Clin Nutr. 2004 Sep;80(3):768-73. doi: 10.1093/ajcn/80.3.768.
- Background: PubMed 16538238Barbarich BN, Willows ND, Wang L, Clandinin MT. Polyunsaturated fatty acids and anthropometric indices of children in rural China. Eur J Clin Nutr. 2006 Sep;60(9):1100-7. doi: 10.1038/sj.ejcn.1602424. Epub 2006 Mar 15.
- Background: PubMed 31388411Kim Y, Kim H, Kwon O. Dietary intake of n-3 and n-6 polyunsaturated fatty acids in Korean toddlers 12-24 months of age with comparison to the dietary recommendations. Nutr Res Pract. 2019 Aug;13(4):344-351. doi: 10.4162/nrp.2019.13.4.344. Epub 2019 Jul 24.
- Background: PubMed 24477258Tsuboyama-Kasaoka N, Takizawa A, Tsubota-Utsugi M, Nakade M, Imai E, Kondo A, Yoshida K, Okuda N, Nishi N, Takimoto H. Dietary intake of nutrients with adequate intake values in the dietary reference intakes for Japanese. J Nutr Sci Vitaminol (Tokyo). 2013;59(6):584-95. doi: 10.3177/jnsv.59.584.
- BackgroundGibson, S. and A. Sidnell, Nutrient adequacy and imbalance among young children aged 1-3 years in the UK. Nutrition bulletin, 2014. 39(2): p. 172-180
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Sunardi, Doctor principal investigator
Faculty of Medicine University of Indonesia Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA Wet Mixing method, DHA Dry Blending Method and Fish Oil in people with Healthy Children, run by Indonesian Nutrition Association at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DHA level in RBC lipid and faecal (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460287, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.