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

Weight Gain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576870
• Other study ID #: Else001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2022
• Source: Else Nutrition GH Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Weight Gain

Intervention

Other:
• Plant based toddler nutrition
Plant based toddler nutrition fed daily ad libitum

Dietary Supplement:
• Dairy based toddler nutrition
Commercially available toddler nutrition fed daily ad libitum

Locations

Country	Name	City	State
United States	Children's Hospital of Colorado	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Else Nutrition GH Ltd	Children's Hosptial of Colorado Aurora, Colorado, United States, Laina VTMS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		4 months
Primary	height velocity		4 months
Secondary	Daily intake	Volume of consumption will be recorded in fluid oz or ml per day	4 months