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

October 8, 2022 updated by: Else Nutrition GH Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital of Colorado
        • Contact:
          • Carina Venter, Dr.
          • Phone Number: 720-777-8886
        • Contact:
          • Phone Number: 720-777-2575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant based toddler nutrition
Plant based toddler nutrition based on almond and buckwheat drink
Other: Plant based toddler nutrition
Plant based toddler nutrition fed daily ad libitum
Active Comparator: Dairy based toddler nutrition
Commercially available dairy based toddler nutrition drink
Dietary supplement: Dairy based toddler nutrition
Commercially available toddler nutrition fed daily ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 4 months
4 months
height velocity
Time Frame: 4 months
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Else Nutrition GH Ltd

Collaborators

Children's Hosptial of Colorado Aurora, Colorado, United States
Laina VTMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 8, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 8, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Else001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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