This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
combination of glycerides in specific proportions in a liquid oral supplement
glycerides used in current formulas in a liquid oral supplement
RBC-DHA levels after 56 days of supplementation
Red blood cell (RBC)-DHA after eight weeks of intervention
Time frame: Study day 56
RBC, plasma additional fatty acids status
Determination of omega-3, omega-6, eicosapentanoic acid, arachidonic acid
Time frame: Study days 0, 14, 28 and 56
DHA supplement intake
Parent-reported supplement intake assessed using a 3-day DHA Supplement Intake and Tolerance Diary
Time frame: Study days 3, 14, 28 and 56
Gastrointestinal (GI) tolerance
Parent-reported GI tolerance indicators assessed using a 3-day DHA Supplement Intake and Tolerance Diary
Time frame: Study days 3, 14, 28 and 56
Weight
Weight measured in grams
Time frame: Study days 0, 14, 28 and 56
Length
Length measured in cm
Time frame: Study days 0, 14, 28 and 56
Head circumference
Head circumference measured in cm
Time frame: Study days 0, 14, 28 and 56
Dietary intakes of DHA and other fatty acids (toddler population only)
Assessed using a 24-hour food recall
Time frame: Study days 0, 28 and 56
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Standard adverse events (AEs) and serious AEs (SAEs) reporting for safety assessment
Incidence of AEs / SAEs reported throughout the study, particular attention will be paid to AEs related to GI tolerance and comfort
Time frame: Study days 0, 14, 28, 56, and 70