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

Healthy Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460287
• Other study ID #: INA/NM-20010028
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Indonesian Nutrition Association
• Contact: Diana Sunardi, Doctor
• Phone: +62816-1646-427
• Email: diana_sunardi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: November 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Children

Intervention

Dietary Supplement:
• DHA Wet Mixing method
Children will drink milk contain 100 mg DHA wet mixing daily for 30 days
• DHA Dry Blending Method
Children will drink milk contain 100 mg DHA dry blending daily for 30 days
• Fish Oil
Children will have this intervention every day for 30 days

Locations

Country	Name	City	State
Indonesia	Sekretariat RW 12 Cipinang besar	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesian Nutrition Association

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DHA level in RBC lipid and faecal	Blood and faecal specimen	One month