Infant NutritionNCT00820833
Effect of Formula on Growth of Infants From Overweight or Obese Mothers
A study testing standard infant formula and Test formula in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth 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 Test formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChile
- Study dates
- Oct 2007to Dec 2014
- 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
- healthy newborn infant
- birth weight between 2500g and 4800g
- singleton birth
- mother's BMI before pregnancy was between 26 and 25
- for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
- for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
- having obtained signed informed consent of legal representative
Who cannot join
- body weight smaller than 5th percentile for that gestational age
- newborn whose mother has diabetes
- newborn whose mother has a drug dependence during pregnancy
- newborn currently participating in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers
The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth
- Conditions
- Infant Nutrition
- Being tested
- standard infant formula, Test formula
- Keywords
- infant formula, obesity, growth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard infant formulaOther
standard infant formula given from 3 to 12 months of age, as per standard requirement
Test formulaOther
Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Standard infant formula Receives: Other: standard infant formula |
| 2 | Experimental | Test formula Receives: Other: Test formula |
| 3 | 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: 3 months
Secondary outcomes (1)
blood test assessments; body composition, bone density
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startOct 2007
- Primary completionJun 2010
- Study completionDec 2014
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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Inostroza, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820833
- Sponsor's protocol ID
- 05.29.INF
- Status last verified
- Dec 2014
- First submitted
- 8 Jan 2009
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Inostroza J, Haschke F, Steenhout P, Grathwohl D, Nelson SE, Ziegler EE. Low-protein formula slows weight gain in infants of overweight mothers. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):70-7. doi: 10.1097/MPG.0000000000000349.
PubMed 24637965
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers
- ClinicalTrials.gov ID
- NCT00820833
- Acronym / sponsor ID
- 05.29.INF
- Conditions
- Infant Nutrition
- Keywords
- infant formula, obesity, growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jan 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 determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: standard infant formulaStandard infant formula |
| 2 | Experimental | Other: Test formulaTest formula |
| 3 | No intervention | –Breastfeeding reference group |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- healthy newborn infant
- birth weight between 2500g and 4800g
- singleton birth
- mother's BMI before pregnancy was between 26 and 25
- for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
Key exclusion criteria (4 listed)
- body weight smaller than 5th percentile for that gestational age
- newborn whose mother has diabetes
- newborn whose mother has a drug dependence during pregnancy
- newborn currently participating in another 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 formulastandard infant formula given from 3 to 12 months of age, as per standard requirement | Other | 1 |
| Test formulaTest formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement. | Other | 2 |
Primary outcome
mean weight gain
Time frame: 3 months
1 secondary outcome
blood test assessments; body composition, bone density
Time frame: 9 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 26 Mar 2015.
- Derived from this study: PubMed 24637965Inostroza J, Haschke F, Steenhout P, Grathwohl D, Nelson SE, Ziegler EE. Low-protein formula slows weight gain in infants of overweight mothers. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):70-7. doi: 10.1097/MPG.0000000000000349.
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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.
Jaime Inostroza, PhD principal investigator
Universidad de La Frontera
1 site 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 Test formula in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Chile.
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 4 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 26 Mar 2015. 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 Chile. 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: 3 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 NCT00820833, 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 26 Mar 2015.