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

NCT04460287 | Completed

• 1 other identifier: INA/NM-20010028
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• DHA level in RBC lipid and faecal

  Blood and faecal specimen

  One month

Study Arms (4)

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.

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

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

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

Dietary Supplement: DHA Wet Mixing method; Dietary Supplement: Fish Oil

Interventions

DHA Wet Mixing method DIETARY_SUPPLEMENT

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

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 Method DIETARY_SUPPLEMENT

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

Milk Drink Fortified with DHA Used Wet Mixing Method; Milk Drink Unfortified (Negative Control); Milk Drink Unfortified Plus Fish Oil (Positive Control)

Fish Oil DIETARY_SUPPLEMENT

Children will have this intervention every day for 30 days

Also known as: Children will have milk drink and Fish Oil contain 100 mg/DHA daily for 30 days

Milk Drink Fortified with DHA Used Dry Blending Method; Milk Drink Fortified with DHA Used Wet Mixing Method; Milk Drink Unfortified (Negative Control)

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indonesian Nutrition Association: lead

Study Sites (1)

Sekretariat RW 12 Cipinang besar

Jakarta, DKI Jakarta, 13410, Indonesia

Location

Related Publications (9)

• 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.

  PMID: 24034437 BACKGROUND

• Osendarp, S.J., The role of omega-3 fatty acids in child development. Oléagineux, Corps gras, Lipides, 2011. 18(6): p. 307-313

  BACKGROUND

• EFSA Panel on Dietetic Products, N.a.A. and Allergies, 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 Journal, 2014. 12(10): p. 3840

  BACKGROUND

• Meyer 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.

  PMID: 12848284 BACKGROUND

• Innis 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.

  PMID: 15321820 BACKGROUND

• Barbarich 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.

  PMID: 16538238 BACKGROUND

• Kim 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.

  PMID: 31388411 BACKGROUND

• Tsuboyama-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.

  PMID: 24477258 BACKGROUND

• Gibson, 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

  BACKGROUND

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Diana Sunardi, Doctor

  Faculty of Medicine University of Indonesia Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: February 17, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 30, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)