Weight GainNCT05576870
Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers
A study testing Plant based toddler nutrition and Dairy based toddler nutrition in people with Weight Gain, run by Else Nutrition GH Ltd at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Plant based toddler nutrition and Dairy based toddler nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Colorado
Denver, Colorado, 80045
Carina Venter, Dr., 720-777-8886
720-777-2575
About this study
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
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
- Being tested
- Plant based toddler nutrition, Dairy based toddler nutrition
- Keywords
- toddler, growth, nutrition
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant based toddler nutritionOther
Plant based toddler nutrition fed daily ad libitum
Dairy based toddler nutritionDietary supplement
Commercially available toddler nutrition fed daily ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Plant based toddler nutrition | Experimental | Plant based toddler nutrition based on almond and buckwheat drink Receives: Other: Plant based toddler nutrition |
| Dairy based toddler nutrition | Active comparator | Commercially available dairy based toddler nutrition drink Receives: Dietary Supplement: Dairy based toddler nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 4 months
height velocity
Measured: 4 months
Secondary outcomes (1)
Daily intake
Volume of consumption will be recorded in fluid oz or ml per day
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Else Nutrition GH Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hosptial of Colorado Aurora, Colorado, United States, Laina VTMS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576870
- Sponsor's protocol ID
- Else001
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05576870
- Acronym / sponsor ID
- Else001
- Conditions
- Weight Gain
- Keywords
- toddler, growth, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Else Nutrition GH LtdIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hosptial of Colorado Aurora, Colorado, United States, Laina VTMS
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant based toddler nutrition | Experimental | Other: Plant based toddler nutritionPlant based toddler nutrition based on almond and buckwheat drink |
| Dairy based toddler nutrition | Active comparator | Dietary Supplement: Dairy based toddler nutritionCommercially available dairy based toddler nutrition drink |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant based toddler nutritionPlant based toddler nutrition fed daily ad libitum | Other | Plant based toddler nutrition |
| Dairy based toddler nutritionCommercially available toddler nutrition fed daily ad libitum | Dietary supplement | Dairy based toddler nutrition |
Primary outcome
Weight gain
Time frame: 4 months
height velocity
Time frame: 4 months
1 secondary outcome
Daily intake
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant based toddler nutrition and Dairy based toddler nutrition in people with Weight Gain, run by Else Nutrition GH Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.