Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers
Primary Purpose
Weight Gain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant based toddler nutrition
Dairy based toddler nutrition
Sponsored by
About this trial
This is an interventional other trial for Weight Gain focused on measuring toddler, growth, nutrition
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Children's Hospital of ColoradoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Plant based toddler nutrition
Dairy based toddler nutrition
Arm Description
Plant based toddler nutrition based on almond and buckwheat drink
Commercially available dairy based toddler nutrition drink
Outcomes
Primary Outcome Measures
Weight gain
height velocity
Secondary Outcome Measures
Daily intake
Volume of consumption will be recorded in fluid oz or ml per day
Full Information
NCT ID
NCT05576870
First Posted
October 6, 2022
Last Updated
October 8, 2022
Sponsor
Else Nutrition GH Ltd
Collaborators
Children's Hosptial of Colorado Aurora, Colorado, United States, Laina VTMS
1. Study Identification
Unique Protocol Identification Number
NCT05576870
Brief Title
Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers
Official Title
Growth Study Using a Toddler Almond Based Nutritional Drink (Test) vs. a. Formula That Has Been Shown to Support Growth (Control) in Healthy Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Else Nutrition GH Ltd
Collaborators
Children's Hosptial of Colorado Aurora, Colorado, United States, Laina VTMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
toddler, growth, nutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plant based toddler nutrition
Arm Type
Experimental
Arm Description
Plant based toddler nutrition based on almond and buckwheat drink
Arm Title
Dairy based toddler nutrition
Arm Type
Active Comparator
Arm Description
Commercially available dairy based toddler nutrition drink
Intervention Type
Other
Intervention Name(s)
Plant based toddler nutrition
Intervention Description
Plant based toddler nutrition fed daily ad libitum
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy based toddler nutrition
Intervention Description
Commercially available toddler nutrition fed daily ad libitum
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
4 months
Title
height velocity
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Daily intake
Description
Volume of consumption will be recorded in fluid oz or ml per day
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Children's Hospital of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Venter, Dr.
Phone
720-777-8886
Phone
720-777-2575
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers
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