Essential Fatty Acid Nutrition For 1-2 Yr-Olds

Study Overview
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Brief Summary
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This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13 months of age. The study will use a classic nutrition design to assess if infants' feeding practices in Canada place infants 1-2 years of age at risk for low long chain polyunsaturated fatty acid (LCPUFA), nutrients known to influence growth, and brain and immune system development. On enrollment, infants will be assigned at random to a nutrition supplement providing omega 6 and omega 3 LCPUFA or a PUFA placebo.

Detailed Description
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The objectives are to1. determine the change in dietary fat and PUFA intakes, change in biochemical measures of fatty acid status prospectively from enrollment to 24 months-of-age and 2. to use a nutritional intervention with LCPUFA to address if limiting status of these nutrients impacts growth and development to 24 months-of-age. Primary Endpoints are distributions of developmental tests scores, growth quality and parental reports of child illness. The Bayley Mental and Motor Scales (BSID-III), Peabody Picture Test, Beery Buktenica Developmental Test, Auditory Continuous Performance Test and Test of Attention and Distractibility are used. Growth is assessed as height, weight, and adipose tissue mass and distribution. Child illness is reported by the parent. Secondary endpoints are physiologic measures of blood pressure, heart rate and heart rate variability, and the genetic variables in fatty acid metabolism on fatty acid status and outcome. Blood is collected at enrolment and at 24 months-of-age. Lipids and fatty acids are assessed on plasma and blood cells. Routine, potentially confounding nutrients including iron, vitamin D, choline, folate and B12 are assessed. DNA is extracted from blood cells for genotyping. Dietary intake is assessed using a food frequency questionnaire (FFQ), 3 day food diaries and 24 hour recalls. A parent report illness dairy and questionnaire modified from the International Study of Asthma and Allergies in Childhood is used to assess illness incidence and duration. Descriptive statistics will be used to present subject characteristics, dietary intakes, growth and physiological measures and test results of total fat. Logistic regression, with multivariable-adjusted odds ratios (ORs) of a negative outcome and corresponding 95% CI will be sued to assess the effect of LCPUFA status on development, growth and health outcomes. For all multivariate models, potential confounders will be screened in stepwise fashion, and any covariate with a regression coefficient P-value < 0.05 (two-sided) will be retained. Performance on tests will be compared as LCPUFA status in the lowest quintile compared to highest quintile of outcome (i.e. the two ends of the distribution differ in LCPUFA status).

Official Title
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Essential Fatty Acid Nutrition in Infants 1 to 2 Years-of-Age

Conditions
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Infant Nutrition

Intervention / Treatment
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* Dietary Supplement: LCPUFA Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: term gestation (37-41 weeks gestation and 2500g or more at birth) single birth English as the primary language in the home non-smoking home environment a healthy infant not yet 13 months-of-age, who is not currently breast-fed or fed infant formula with ARA and DHA. primary milk source is cows' milk, cows' milk substitutes, or other milk substitutes containing no supplemental fatty acids from enrollment to 24 months-of age. the infant has no known food allergies, metabolic, neurological, genetic, or immune disorders that are likely, in the opinion of the investigator to impact the outcome measures in this study. the infant has not been fatty acid or oil, including fish oil supplements and there is no intent to provide these supplements during the study. the infant has no history of hospitalization, growth failure or any other event which in the opinion of the investigator is likely to impact the outcome measures in this study. Exclusion Criteria: any infant that does not meet the inclusion criteria will not be included in this study.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 13 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 |
| --- | --- |
| Active Comparator: LCPUFA Supplement<br>DHA/ARA supplement providing 200 mg/day docosahexaenoic acid (DHA) from DHASCO®-S oil and 200 mg/day arachidonic acid (ARA) from ARASCO® oil (DSM Nutritional Products). | Dietary Supplement: LCPUFA Supplement<br>* Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age<br>|
| Placebo Comparator: A Placebo<br>400 mg/day corn oil | Dietary Supplement: Placebo<br>* Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental test scores | Bayley Scales of Infant and Toddler Development 3rd Edition and Beery-Buktenica Developmental Test of Visual -Motor Integration (5th Ed) composite scores at 24 months in relation to LCPUFA supplement group. | 12 months (at 24 months of age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and Red Blood Cell fatty acids (% total fatty acids) | Plasma and red blood cell fatty acids levels in relation to dietary LCPUFA intake | 12 months (at 24 months of age) | 
| Systolic and diastolic blood pressure (mmHg) | In clinic systolic and diastolic blood pressure in relation to LCPUFA status | 12 months (at baseline and 24 months of age) | 
| Heart rate and heart rate variability | Heart rate and heart rate variability in relation to LCPUFA status | 12 months (at baseline and 24 months of age) | 
| Genetic variation in fatty acid desaturases | Genetic variation in fatty acid desaturases in relation to LCPUFA status | 12 months (at 24 months of age) | 
| Hemoglobin (g/dL) | Hemoglobin concentration in relation to diet | 12 months (at baseline and 24 months of age) | 
| Ferritin (ng/ml) | Serum ferritin in relation to child diet | 12 months (at baseline and 24 months of age) | 
| Choline metabolites (umol/L) | Plasma free choline, betaine, and dimethylglycine in relation to child diet | 12 months (at baseline and 24 months of age) | 
| Folate (nmol/L) | Serum folate in relation to child diet | 12 months (at baseline and 24 months of age) | 
| Vitamin B12 (pmol/L) | Serum vitamin B12 in relation to child diet | 12 months (at baseline and 24 months of age) | 
| Vitamin D (nmol/L) | Serum vitamin D in relation to child diet | 12 months (at baseline and 24 months of age) | 
| Supplements and supplemented foods | Use of nutrient supplements and supplemented foods and child nutrient status. | 12 months (at baseline and age 18 and 24 months) | 
| Growth (weight, kg) | Weight of at baseline, 18 and 24 months in relation to LCPUFA | 12 months (at baseline and age 18 and 24 months) | 
| Growth (height) | Height at baseline, 18 and 24 months in relation to LCPUFA | 12 months (at baseline and age 18 and 24 months) | 
| Growth (BMI, kg/m2) | BMI at baseline, 18 and 24 months in relation to LCPUFA | 12 months (at baseline and age 18 and 24 months) | 
| Growth (waist circumference, cm) | Waist circumference at baseline, 18 and 24 months in relation to LCPUFA | 12 months (at baseline and age 18 and 24 months) | 
| Incidence and duration of illness | Parental reports of illness and duration | 12 months (at baseline and age 18 and 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyunsaturated fatty acids, Cognitive development, Growth, Infection