DHA Proof-of-Concept Study in Infants and Toddlers

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Liquid Oral Supplement Comprising a Blend of Glycerides at Certain Proportions on Infant and Toddler DHA Status

Conditions
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Infants, Toddlers, Nutritional Supplement

Intervention / Treatment
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* Other: blend of glycerides at certain proportions
* Other: glycerides used in current formulas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who fulfil all of the following inclusion criteria will be included: Evidence of personally signed and dated informed consent form indicating that the infant/toddler's parent(s)/ Legally Authorized representative (LAR) has been informed of all pertinent aspects of the study. Infants/toddlers whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol. Infants/toddlers must meet the following inclusion criteria respectively to be eligible for enrollment into the study: Healthy normally developing infant/toddler at the discretion of the investigator. Healthy term infant (37-42 weeks of gestation) at birth. At enrollment visit, post-natal age 2-3 months (60-90 days) for infants or 13-14 months for toddlers (date of birth = day 0). For the infant group, infants must have been exclusively consuming and tolerating a cow's milk infant formula not containing DHA for the past month, and their parent(s)/LAR must have independently elected, before enrolment, not to breastfeed. For the toddler group, toddlers must have been consuming and tolerating a cow's milk TMS not containing DHA for the past month. Infants or toddlers must not have been consuming DHA-containing supplements for the past month. Exclusion Criteria: Any of the following criteria would render a subject ineligible for inclusion: Infants/toddlers with conditions requiring feedings other than those specified in the protocol. Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 grams (g) per day of complementary foods or liquids at enrollment. Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal (e.g., complicated gastroesophageal reflux combined with inadequate growth and/or respiratory complications, Hirschsprung's disease), or other systemic diseases. History of admission to the Neonatal Intensive Care Unit, with the exception of admission for jaundice phototherapy. Currently participating or having participated in another clinical trial since birth. Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant/toddler inappropriate for entry into the study. Infants/toddlers who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., lactase enzymes, pancreatic enzymes); medications that may neutralize or suppress gastric acid secretion; medications that could affect any study outcomes. Infants/toddlers whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 14 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPL<br>Liquid oral supplement comprising a blend of glycerides at certain proportions | Other: blend of glycerides at certain proportions<br>* combination of glycerides in specific proportions in a liquid oral supplement<br>|
| Other: CTRL<br>Liquid oral supplement comprising glycerides used in current formulas | Other: glycerides used in current formulas<br>* glycerides used in current formulas in a liquid oral supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC-DHA levels after 56 days of supplementation | Red blood cell (RBC)-DHA after eight weeks of intervention | Study day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC, plasma additional fatty acids status | Determination of omega-3, omega-6, eicosapentanoic acid, arachidonic acid | 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 | 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 | Study days 3, 14, 28 and 56 | 
| Weight | Weight measured in grams | Study days 0, 14, 28 and 56 | 
| Length | Length measured in cm | Study days 0, 14, 28 and 56 | 
| Head circumference | Head circumference measured in cm | 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 | Study days 0, 28 and 56 | 
| 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 | Study days 0, 14, 28, 56, and 70 |