Growth study using a Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers
To investigate the effect of the almond based nutritional drink (AND) on weight gain in toddlers as compared to a standard toddler formula (Enfagrow) based on cow’s milk protein. We hypothesize that mean weight gain between AND and Enfagrow groups will be similar. Both AND and Enfagrow may be referred to as formula for the remainder of this document.
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Enrolling toddlers (age 1-3 years old). Consuming and tolerating a cow's milk and almond at the time of enrollment
1. Gestational age between 37 weeks + 0 days and 41 weeks + 6 days, 2. Weight for age; 5th and 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts 3. Length for age 5th and 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts 4. Weight for length for age 5th and 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts 5. Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions) 6. 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
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Childrens Hospital Colorado
Carina Venter, PhD, RD
Protocol Number: 21-4644
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