Weight GainNCT05508750
Growth and Safety Clinical Trial on a New Infant Formula
A study testing New Infant Formula and Commercial Infant Formula in people with Weight Gain, run by Jovie USA, LLC at 1 site in United States.
Trial summary
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula… Read more about this study
- Who is it for?
- Ages 0 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- New Infant Formula and Commercial Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 2 Jan 2024
- 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 0 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal term infant (37-42 weeks gestation at birth)
- Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0
- Infant birth weight of ≥2500 g (5.5 lbs.)
- Healthy Infant
- Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
- Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
- Caregiver willing and able to sign informed consent
Who cannot join
- Infant born in multiple birth (i.e., twins, triplets, etc.)
- Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
- Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- Caregiver intent to feed non-study formula or solid food during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.
- Conditions
- Weight Gain
- Being tested
- New Infant Formula, Commercial Infant Formula
- Keywords
- infant, formula, in-home
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Infant FormulaOther
New infant formula fed daily ad libitum
Commercial Infant FormulaOther
Commercially available infant formula fed daily ad libitum
| Study group | Role | What they receive |
|---|---|---|
| New Infant Formula | Experimental | New infant formula for healthy term infants Receives: Other: New Infant Formula |
| Commercial Infant Formula | Active comparator | Standard, commercially available infant formula for healthy term infants Receives: Other: Commercial Infant Formula |
| Human Milk | No intervention | Breastfed infants serve as a reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain from baseline to 16 weeks feeding
Weight gain g/day
Measured: 16 weeks
Secondary outcomes (3)
Length gain from baseline to 16 weeks feeding
Length gain
Measured: 16 weeks
Head Circumference gain from baseline to 16 weeks feeding
Head Circumference gain
Measured: 16 weeks
Volume of formula consumed during 3-consecutive day intervals
Volume of formula consumed
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start21 Sep 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
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
- Model description
- A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jovie USA, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Parth Shah, MD FAPCR, Principal investigator, ObvioHealthDawn Ross, Director Clinical Project Management, Study director, IQVIA RDS Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508750
- Sponsor's protocol ID
- IQV-JOV-001
- Status last verified
- Jan 2024
- First submitted
- 18 Aug 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
- ClinicalTrials.gov ID
- NCT05508750
- Acronym / sponsor ID
- IQV-JOV-001
- Conditions
- Weight Gain
- Keywords
- infant, formula, in-home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Jovie USA, LLCIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., ObvioHealth
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 19 Aug 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 this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
| Arm | Type | Receives |
|---|---|---|
| New Infant Formula | Experimental | Other: New Infant FormulaNew infant formula for healthy term infants |
| Commercial Infant Formula | Active comparator | Other: Commercial Infant FormulaStandard, commercially available infant formula for healthy term infants |
| Human Milk | No intervention | –Breastfed infants serve as a reference group |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Normal term infant (37-42 weeks gestation at birth)
- Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0
- Infant birth weight of ≥2500 g (5.5 lbs.)
- Healthy Infant
- Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
Key exclusion criteria (5 listed)
- Infant born in multiple birth (i.e., twins, triplets, etc.)
- Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
- Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
- Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
- Caregiver intent to feed non-study formula or solid food during 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 |
|---|---|---|
| New Infant FormulaNew infant formula fed daily ad libitum | Other | New Infant Formula |
| Commercial Infant FormulaCommercially available infant formula fed daily ad libitum | Other | Commercial Infant Formula |
Primary outcome
Weight gain from baseline to 16 weeks feeding
Time frame: 16 weeks
Weight gain g/day
3 secondary outcomes
Length gain from baseline to 16 weeks feeding
Time frame: 16 weeks
Head Circumference gain from baseline to 16 weeks feeding
Time frame: 16 weeks
Volume of formula consumed during 3-consecutive day intervals
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Parth Shah, MD FAPCR principal investigator
ObvioHealth
Dawn Ross, Director Clinical Project Management study director
IQVIA RDS Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Infant Formula and Commercial Infant Formula in people with Weight Gain, run by Jovie USA, LLC 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain from baseline to 16 weeks feeding (time frame: 16 weeks). 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 17 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.