Recruiting

Else vs. Dairy

Sponsor:

Else Nutrition GH Ltd

Code:

NCT05576870

Conditions

Weight Gain

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

Interventions

Plant based toddler nutrition

Dairy based toddler nutrition

Study Details

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

Conditions

Weight Gain

Study ID

NCT05576870

Start date

Oct 1, 2022

Status verified date

Oct, 2022

Completion date

May 31, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

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 Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Plant based toddler nutrition

Plant based toddler nutrition based on almond and buckwheat drink

active comparator: Dairy based toddler nutrition

Commercially available dairy based toddler nutrition drink

Interventions

Plant based toddler nutrition

Plant based toddler nutrition fed daily ad libitum

Dairy based toddler nutrition

Commercially available toddler nutrition fed daily ad libitum

Primary outcome measure

  • Weight gain [ Time Frame: 4 months ]
  • height velocity [ Time Frame: 4 months ]

Central Contacts and Locations

Locations

Children's Hospital of Colorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

Carina Venter, Dr.

720-777-8886

More Information

Sponsor

Else Nutrition GH Ltd

Last update posted

Oct 13, 2022

Last verified

Oct, 2022

Keywords

  • toddler
  • growth
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Else Nutrition GH Ltd on 2022-10-13.