None listed
Conditions
Brief summary
Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) are known to play a critical role in both maternal health and infant development, and have a particularly important role in protection against preterm delivery and in ensuring the optimal development of the brain and visual system of the fetus and infant (Makrides & Gibson, Med J Aust, 2002; Demmelmair & Koletzko, World Rev Nutr Dietet, 2015). Achieving and maintaining an adequate supply of these fatty acids during pregnancy and breastfeeding is therefore of vital importance for both short and long term health outcomes of the infant. Recent studies have suggested that many women of childbearing age in many countries, including Australia and the US, fail to meet the recommended levels of intake of these fatty acids, and as a result have a low omega-3 status (Meyer, Nutrients, 2016). Therefore, there is a concern that a significant proportion of women have an insufficient omega-3 status during pregnancy and while breastfeeding in order to meet the needs of their infant. In addition, fish consumption in the majority of these countries also remains low, and therefore these women rely predominately on omega-3 supplements in order to increase their omega-3 status. It is also known, however, that the bioavailability of different supplements into human blood and breast milk can vary significantly according to the formulation and form in which the fatty acids are provided. This is particularly important in the case of women who are breastfeeding, since the uptake of supplements into breast milk depends on both the efficiency of uptake into the maternal circulation, and the transfer of these fatty acids to the breast milk. As such, it is vital to directly test the ability of supplements provided to lactating women to be taken up into the breast milk. The primary objective of this study is to assess the effect of supplementing breastfeeding women with the Pronovum formulation PRF-037 (150:500 Ethyl Ester in SMEDDS) on concentrations of DHA and EPA in breast milk after 4 weeks of supplementation.
Interventions
Intervention capsule (High omega-3 oil blend) Capsules of DHA enriched fish oil based high concentrated omega-3-acid oil formulation based on PronovaPure 150:500 EE EU. Each capsule contains 467 mg of omega-3 fatty acid ethyl esters (169 mg of EPA and 298 mg of DHA ethyl esters). - each participant will be randomly assigned to either the control or intervention group - participants will be asked to consume 2 oral capsules (1000mg per capsule, 2000mg total/day) per day for 4 weeks Women will be asked to return unused supplements at the end of the study. The proportion of capsules returned will serve as a measure of adherence. Blood omega-3 concentrations at the end of intervention will be used as an independent biomarker of adherence.
Sponsors
Study design
Eligibility
Inclusion criteria
-Singleton pregnancy -Intending to or currently breastfeeding -Willing to take capsules containing fish-oil -Infant younger than 4 weeks or equal to older than 12 months of age
Exclusion criteria
-Currently pregnant -BMI greater than 40kg/m2 -Regularly taking high dose fish-oil supplements ( greater than 250mg DHA/day) -Taking fish-oil supplements (less than or equal to 250mg DHA/day) and not willing to stop at least 4 weeks prior to commencing this study -Bleeding disorder in which fish-oil is contraindicated -Maternal diseases known to affect gastric absorption -Participation in other RCTs involving omega-3 LCPUFA supplementation during lactation