← Back to Search

New Infant Formula for Obesity

N/A
Waitlist Available
Led By Parth Shah, MD FAPCR
Research Sponsored by Jovie USA, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will compare the growth of infants who are fed a new infant formula to those who are fed a standard, commercially-available infant formula. A reference group of human milk-fed infants will also be enrolled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight gain from baseline to 16 weeks feeding
Secondary outcome measures
Head Circumference gain from baseline to 16 weeks feeding
Length gain from baseline to 16 weeks feeding
Volume of formula consumed during 3-consecutive day intervals
Other outcome measures
Assessment of AEs
Caregiver report of stool characteristics obtained during 3-consecutive day intervals
Caregiver report of tolerance obtained during 3-consecutive day intervals
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: New Infant FormulaExperimental Treatment1 Intervention
New infant formula for healthy term infants
Group II: Commercial Infant FormulaActive Control1 Intervention
Standard, commercially available infant formula for healthy term infants
Group III: Human MilkActive Control1 Intervention
Breastfed infants serve as a reference group

Find a Location

Who is running the clinical trial?

Jovie USA, LLCLead Sponsor
IQVIA RDS Inc.UNKNOWN
3 Previous Clinical Trials
13,978 Total Patients Enrolled
ObvioHealthIndustry Sponsor
11 Previous Clinical Trials
10,840 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently have a recruitment process?

"The data presented on clinicaltrials.gov demonstrates that this research is currently recruiting participants, with the initial posting date being September 21st 2022 and the most recent update recorded as the 27th of that same month."

Answered by AI

What is the enrollment size for this research endeavor?

"Indeed, records from clinicaltrials.gov demonstrate that enrollment for this trial is currently ongoing. The research was initially posted on September 21st 2022 and most recently updated a week later; 240 people are required to be recruited at 1 site."

Answered by AI

Can I take part in this scientific research?

"This investigation seeks to enrol 240 newborns aged between 0 and 14 days who have experienced weight gain. Essential criteria for selection include: normal gestational age at birth, less than 15 (+3) days old when the study begins, a minimum birth weight of 2500 grams (5.5 lbs.), good general health, caregivers willing to objectively measure feeding behaviours, sign informed consent forms, and continue their current breastfeeding or formula-feeding methods throughout the trial period."

Answered by AI

Does this clinical trial provide opportunities for those below the age of 70 years?

"This medical study is seeking infants aged 0 Days to 14 Days, while there are 17 other trials that accommodate minors and 28 for senior citizens."

Answered by AI
~163 spots leftby Apr 2025