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

E

Else Nutrition GH

Status

Enrolling

Conditions

Weight Gain

Treatments

Dietary Supplement: Dairy based toddler nutrition
Other: Plant based toddler nutrition

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT05576870
Else001

Details and patient eligibility

About

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

Enrollment

128 estimated patients

Sex

All

Ages

1 to 3 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  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

Exclusion criteria

  1. Toddler with any positive food allergy test food allergy or intolerance to any foods
  2. Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

128 participants in 2 patient groups

Plant based toddler nutrition
Experimental group
Description:
Plant based toddler nutrition based on almond and buckwheat drink
Treatment:
Other: Plant based toddler nutrition
Dairy based toddler nutrition
Active Comparator group
Description:
Commercially available dairy based toddler nutrition drink
Treatment:
Dietary Supplement: Dairy based toddler nutrition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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