Infant NutritionNCT00716105
Effect of the Level of Dietary Protein on Infant Growth
A study testing Standard infant formula and Infant formula with different level of proteins in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development. Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- Standard infant formula and Infant formula with different level of proteins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Feb 2015
- 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 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age at least 37 weeks
- Singleton birth
- Birth weight between 2500g and 4500g
- Weight at enrolment is at or above the 5th percentile (CDC)
- Infant has been exclusively formula fed for at least the last 14 days
- Having obtained informed consent of legal representative
Who cannot join
- Congenital illness or malformation that affects infant feeding and/or growth
- Significant pre-natal and/or post-natal disease
- Suspected or confirmed allergy to cow milk protein
- In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
- Currently participating in another clinical trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
Iowa City, Iowa, 52242
Department of Pediatrics University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73102
About this study
Official title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.
- Conditions
- Infant Nutrition
- Being tested
- Standard infant formula, Infant formula with different level of proteins
- Keywords
- Infant formula, Protein metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard infant formulaOther
From 3 to 12 months of age. As per standard requirement
Infant formula with different level of proteinsOther
From 3 to 12 months of age. As per standard requirement
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Standard Infant Formula Receives: Other: Standard infant formula |
| Test Product | Experimental | Infant formula with different level of proteins Receives: Other: Infant formula with different level of proteins |
| Breast Milk | No intervention | Breastfeeding reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weight gain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionFeb 2015
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 Infant NutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekhard E Ziegler, MD, Principal investigator, The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716105
- Sponsor's protocol ID
- 06.29.INF
- Status last verified
- Oct 2014
- First submitted
- 11 Jul 2008
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ziegler EE, Fields DA, Chernausek SD, Steenhout P, Grathwohl D, Jeter JM, Nelson SE, Haschke F. Adequacy of Infant Formula With Protein Content of 1.6 g/100 kcal for Infants Between 3 and 12 Months. J Pediatr Gastroenterol Nutr. 2015 Nov;61(5):596-603. doi: 10.1097/MPG.0000000000000881.
PubMed 26154030
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
- ClinicalTrials.gov ID
- NCT00716105
- Acronym / sponsor ID
- 06.29.INF
- Conditions
- Infant Nutrition
- Keywords
- Infant formula, Protein metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jul 2008 (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 determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Standard infant formulaStandard Infant Formula |
| Test Product | Experimental | Other: Infant formula with different level of proteinsInfant formula with different level of proteins |
| Breast Milk | No intervention | –Breastfeeding reference group |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational age at least 37 weeks
- Singleton birth
- Birth weight between 2500g and 4500g
- Weight at enrolment is at or above the 5th percentile (CDC)
- Infant has been exclusively formula fed for at least the last 14 days
Key exclusion criteria (5 listed)
- Congenital illness or malformation that affects infant feeding and/or growth
- Significant pre-natal and/or post-natal disease
- Suspected or confirmed allergy to cow milk protein
- In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
- Currently participating in another clinical trial
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 |
|---|---|---|
| Standard infant formulaFrom 3 to 12 months of age. As per standard requirement | Other | Control |
| Infant formula with different level of proteinsFrom 3 to 12 months of age. As per standard requirement | Other | Test Product |
Primary outcome
Mean weight gain
Time frame: 6 months
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 19 May 2015.
- Derived from this study: PubMed 26154030Ziegler EE, Fields DA, Chernausek SD, Steenhout P, Grathwohl D, Jeter JM, Nelson SE, Haschke F. Adequacy of Infant Formula With Protein Content of 1.6 g/100 kcal for Infants Between 3 and 12 Months. J Pediatr Gastroenterol Nutr. 2015 Nov;61(5):596-603. doi: 10.1097/MPG.0000000000000881.
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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.
Ekhard E Ziegler, MD principal investigator
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard infant formula and Infant formula with different level of proteins in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 2 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 6 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Mean weight gain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00716105, 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 19 May 2015.