HealthyNCT00916565
Evaluation of Cow Milk-Based Formulas - Functional Proteins
An observational study of Healthy, run by Mead Johnson Nutrition at 11 sites in United States.
Trial summary
The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula. Read more about this study
- Who is it for?
- Ages 10 to 18 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 139 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2009to not given
- Phase
- Observational
- 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 10 to 18 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: formula-fed and breastfed infants
Who may be able to join
- 10-18 days of age
- 37-42 weeks gestation
- birth weight 2500 g or more
- consuming one source of nutrition
Who cannot join
- metabolic or chronic disease
- acute infection
- feeding difficulties
- consumed complementary foods or donor milk
- steroid use
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Beth Nauert, MD
Austin, Texas, 78745
Dr. Claude Ashley
Birmingham, Alabama, 35235
William Johnston, MD
Birmingham, Alabama, 35235
Laurie Harris-Ford, MD
Clarksville, Tennessee, 37043
Susan Carlson, Ph.D.
Kansas City, Kansas, 66160
Edward Zissman, MD
Lake Mary, Florida, 32746
Lori Montgomery, MD
Little Rock, Arkansas, 72205
Ann Grandjean, Ed. D
Omaha, Nebraska, 68105
Harold Deulofeut MD
Plantation, Florida, 33324
Harold Deulofeut MD
Tamarac, Florida, 33321
Joseph Leader, MD
Woburn, Massachusetts, 01801
About this study
Official title: The Evaluation of Cow Milk-Based Formulas - Functional Proteins
The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.
- Conditions
- Healthy
- Keywords
- optimize nutritional content of infant formula, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental milk-based infant formula | Not described | |
| Control milk-based infant formula | Not described | |
| Breastfed Reference Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916565
- Sponsor's protocol ID
- 3378-3
- Status last verified
- Aug 2011
- First submitted
- 5 Jun 2009
- Last updated
- 2 Sep 2011
- Results posted
- No
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Cow Milk-Based Formulas - Functional Proteins
- ClinicalTrials.gov ID
- NCT00916565
- Acronym / sponsor ID
- 3378-3
- Conditions
- Healthy
- Keywords
- optimize nutritional content of infant formula, Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- First posted
- 9 Jun 2009 (estimated)
- 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 purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental milk-based infant formula | – | – |
| Control milk-based infant formula | – | – |
| Breastfed Reference Group | – | – |
Who may qualify
- Ages
- 10 to 18 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- formula-fed and breastfed infants
Key inclusion criteria (4 listed)
- 10-18 days of age
- 37-42 weeks gestation
- birth weight 2500 g or more
- consuming one source of nutrition
Key exclusion criteria (5 listed)
- metabolic or chronic disease
- acute infection
- feeding difficulties
- consumed complementary foods or donor milk
- steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Sep 2011.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mead Johnson Nutrition at 11 sites 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 4 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 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916565, which also lists 1 linked publication.
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 2 Sep 2011.