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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05576870

Enrollment

128

Registered

2022-10-13

Start date

2022-10-01

Completion date

2023-05-31

Last updated

2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Gain

Keywords

toddler, growth, nutrition

Brief summary

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

Interventions

OTHERPlant based toddler nutrition

Plant based toddler nutrition fed daily ad libitum

DIETARY_SUPPLEMENTDairy based toddler nutrition

Commercially available toddler nutrition fed daily ad libitum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Weight gain	4 months
height velocity	4 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026