Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers

Study Overview
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Brief Summary
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The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers

Official Title
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Growth Study Using a Toddler Almond Based Nutritional Drink (Test) vs. a. Formula That Has Been Shown to Support Growth (Control) in Healthy Toddlers

Conditions
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Weight Gain

Intervention / Treatment
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* Other: Plant based toddler nutrition
* Dietary Supplement: Dairy based toddler nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days, Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions) Consuming and tolerating almond on more than one occasion in age appropriated doses, to ensure no reaction to study formula e.g. 2 teaspoons almond butter in one portion or 500 ml/16 fl oz per day Exclusion Criteria: Toddler with any positive food allergy test food allergy or intolerance to any foods Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

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: Plant based toddler nutrition<br>Plant based toddler nutrition based on almond and buckwheat drink | Other: Plant based toddler nutrition<br>* Plant based toddler nutrition fed daily ad libitum<br>|
| Active Comparator: Dairy based toddler nutrition<br>Commercially available dairy based toddler nutrition drink | Dietary Supplement: Dairy based toddler nutrition<br>* Commercially available toddler nutrition fed daily ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 4 months | 
| height velocity |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily intake | Volume of consumption will be recorded in fluid oz or ml per day | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toddler, growth, nutrition