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Status unknownNCT05576870Updated Oct 13, 2022

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

An interventional study of Plant based toddler nutrition and Dairy based toddler nutrition in Weight Gain, sponsored by Else Nutrition GH Ltd. Status unknown at 1 site in United States. Open to participants aged 1 Year to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Else Nutrition GH Ltd · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
1 Year to 3 Years
Sex
All
01

Study 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

02

Conditions studied

  • Weight Gain

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Keywords

  • toddler
  • growth
  • nutrition
03

In context

Weight Gain

405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.

This study's planned enrollment of 128 is above the median of 83 across 324 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

This is the only study on the registry with Else Nutrition GH Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 3 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    Plant based toddler nutrition

    Plant based toddler nutrition based on almond and buckwheat drink

    Other: Plant based toddler nutrition

  • Active comparator
    Dairy based toddler nutrition

    Commercially available dairy based toddler nutrition drink

    Dietary Supplement: Dairy based toddler nutrition

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

06

What researchers measure

Primary outcomes

  1. Weight gain

    Time frame: 4 months

  2. height velocity

    Time frame: 4 months

Secondary outcomes

  1. Daily intake

    Volume of consumption will be recorded in fluid oz or ml per day

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Children's Hospital of Colorado
    Denver, Colorado 80045, United States
    • Carina Venter, Dr. · Contact · 720-777-8886
    • · Contact · 720-777-2575
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05576870
Lead sponsor
Else Nutrition GH Ltd
Collaborators
Children's Hosptial of Colorado Aurora, Colorado, United States, Laina VTMS
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Oct 1, 2022
Primary completion
May 31, 2023 (estimated)
Completion
May 31, 2023 (estimated)
Last update
Oct 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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