The Feasibility of the “Omega Kid” Study Protocol: A Double-Blind, Randomised, Placebo-Controlled Trial Investigating the Effect of Omega-3 Supplementation on Self-Regulation in Preschool-Aged Children

Abstract

Self-regulation, the regulation of behaviour in early childhood, impacts children’s success at school and is a predictor of health, wealth, and criminal outcomes in adulthood. Self-regulation may be optimised by dietary supplementation of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFAs). The aim of the “Omega Kid” study is to investigate the feasibility of a protocol to investigate whether n-3 LCPUFA supplementation enhances self-regulation in preschool-aged children. The protocol assessed involved a double-blind, randomised, placebo-controlled trial of 12 weeks duration, with an intervention of 1.6 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day (0.3 g EPA and 1.3 g DHA) in a microencapsulated powder compared to placebo. Children (n = 78; 40 boys and 38 girls) aged 3–5 years old were recruited and randomly allocated to the treatment (n = 39) or placebo group (n = 39). The HS–Omega-3 Index® served as a manipulation check on the delivery of either active (n-3 LCPUFAs) or placebo powders. Fifty-eight children (76%) completed the intervention (28–30 per group). Compliance to the study protocol was high, with 92% of children providing a finger-prick blood sample at baseline and high reported-adherence to the study intervention (88%). Results indicate that the protocol is feasible and may be employed in an adequately powered clinical trial to test the hypothesis that n-3 LCPUFA supplementation will improve the self-regulation of preschool-aged children.

Effect of Omega-3 Supplementation on Self-Regulation in Typically Developing Preschool-Aged Children: Results of the Omega Kid Pilot Study—A Randomised, Double-Blind, Placebo-Controlled Trial

“…The strengths of this study include: (1) a protocol that was found to be feasible and acceptable by participating families [28]; (2) the use of a highly bioavailable novel omega-3 supplement; (3) successful blinding of the treatment with no difference between groups for parents correctly guessing their child's treatment allocation; (4) the use of validated outcome measures such as the PUFA FFQ; (5) and a specific focus on self-regulation, with previous studies in this age group focussing more broadly on cognitive functions [22][23][24]. Another strength is measuring HS-Omega-3 Index ® as recommended by the International Study for the Fatty Acids and Lipids (ISSFAL) Official Statement Number 6: the importance of measuring blood omega-3 long chain polyunsaturated fatty acid levels in research [56].…”

“…This manuscript adheres to the CONSORT guidelines for pilot and feasibility trials (Table S1 CONSORT Checklist). The feasibility of the study protocol has been assessed and reported elsewhere [28].…”

“…Details of the intervention have been published [28]. In brief, the intervention was single serve sachets of powder containing either microencapsulated Tuna Oil powder (Driphorm ® HiDHA ® 50) for the n-3 LCPUFA group or high oleic acid sunflower oil powder for the placebo group.…”

“…From the 38 in each group who commenced treatment, 8 withdrew in the omega-3 group and 10 withdrew in the placebo group. Thirty children in the omega-3 group completed the intervention, however 29 were included in the analysis as one child commenced medication for a behavioural condition midway through the trial and was removed from the final analysis but was able to be included in previous feasibility analysis [28]. In the placebo group, 28 children completed the intervention and were included in the analysis.…”