Growth Study Using Else Toddler Nutritional Drink vs. a.... | NCT05576870

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

NCT05576870

Sponsor

Else Nutrition GH Ltd

Status

Unknown status

Last Update Posted

Oct 13, 2022Actual

Enrollment

128Estimated

Phase

Not Applicable

Conditions

Weight Gain

Interventions

Plant based toddler nutrition
Dairy based toddler nutrition

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

May 31, 2023Estimated

Completion Date

May 31, 2023Estimated

First Submitted Date

Oct 6, 2022

First Submission Date that Met QC Criteria

Oct 8, 2022

First Posted Date

Oct 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2022

Last Update Posted Date

Oct 13, 2022Actual

Name	Class
Children's Hosptial of Colorado Aurora, Colorado, United States	UNKNOWN
Laina VTMS	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plant based toddler nutrition	Experimental	Plant based toddler nutrition based on almond and buckwheat drink	Other: Plant based toddler nutrition
Dairy based toddler nutrition	Active Comparator	Commercially available dairy based toddler nutrition drink	Dietary Supplement: Dairy based toddler nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plant based toddler nutrition	Other	Plant based toddler nutrition fed daily ad libitum	Plant based toddler nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight gain		4 months
height velocity		4 months

Secondary Outcomes

Measure	Description	Time Frame
Daily intake	Volume of consumption will be recorded in fluid oz or ml per day	4 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Colorado	Recruiting	Denver	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015430	Weight Gain

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided