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CompletedNCT00820833Updated Mar 26, 2015

Effect of Formula on Growth of Infants From Overweight or Obese Mothers

An interventional study of standard infant formula and Test formula in Infant Nutrition, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Chile. Open to participants aged 3 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
3 Months to 12 Months
Sex
All
01

Study 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

02

Conditions studied

  • Infant Nutrition

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Keywords

  • infant formula
  • obesity
  • growth
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 230 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Browse Société des Produits Nestlé (SPN) studies →All Nestlé S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
230 participants (actual)

Study arms

  • Placebo comparator
    1

    Standard infant formula

    Other: standard infant formula

  • Experimental
    2

    Test formula

    Other: Test formula

  • No intervention
    3

    Breastfeeding reference group

Interventions

  • Otherstandard infant formula

    standard infant formula given from 3 to 12 months of age, as per standard requirement

  • OtherTest formula

    Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.

06

What researchers measure

Primary outcomes

  1. mean weight gain

    Time frame: 3 months

Secondary outcomes

  1. blood test assessments; body composition, bone density

    Time frame: 9 months

07

Study locations

1 site
  • Departamento de Medicina Interna, University de la Frontera
    Temuco, Chile
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2007, a primary completion of Jun 2010 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2009
First posted
Jan 12, 2009
Start
Oct 2007
Primary completionActual
Jun 2010
CompletionActual
Dec 2014
Last update
Mar 26, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00820833
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Jan 12, 2009
Start date
Oct 2007
Primary completion
Jun 2010
Completion
Dec 2014
Last update
Mar 26, 2015

Study contacts

Jaime Inostroza, PhD
principal investigator · Universidad de La Frontera

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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