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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-05-31

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

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Detailed Description

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Conditions

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Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Plant based toddler nutrition

Plant based toddler nutrition based on almond and buckwheat drink

Group Type EXPERIMENTAL

Plant based toddler nutrition

Intervention Type OTHER

Plant based toddler nutrition fed daily ad libitum

Dairy based toddler nutrition

Commercially available dairy based toddler nutrition drink

Group Type ACTIVE_COMPARATOR

Dairy based toddler nutrition

Intervention Type DIETARY_SUPPLEMENT

Commercially available toddler nutrition fed daily ad libitum

Interventions

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Plant based toddler nutrition

Plant based toddler nutrition fed daily ad libitum

Intervention Type OTHER

Dairy based toddler nutrition

Commercially available toddler nutrition fed daily ad libitum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes