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
1 other identifier
interventional
128
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedOctober 13, 2022
October 1, 2022
8 months
October 6, 2022
October 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight gain
4 months
height velocity
4 months
Secondary Outcomes (1)
Daily intake
4 months
Study Arms (2)
Plant based toddler nutrition
EXPERIMENTALPlant based toddler nutrition based on almond and buckwheat drink
Dairy based toddler nutrition
ACTIVE COMPARATORCommercially available dairy based toddler nutrition drink
Interventions
Plant based toddler nutrition fed daily ad libitum
Commercially available toddler nutrition fed daily ad libitum
Eligibility Criteria
You may qualify if:
- Gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days,
- Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions)
- 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
You may not qualify if:
- Toddler with any positive food allergy test food allergy or intolerance to any foods
- Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Else Nutrition GH Ltdlead
- Children's Hosptial of Colorado Aurora, Colorado, United Statescollaborator
- Laina VTMScollaborator
Study Sites (1)
Children's Hospital of Colorado
Denver, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 13, 2022
Study Start
October 1, 2022
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
October 13, 2022
Record last verified: 2022-10