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

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT00820833

Collaborator

(none)

230

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Infant Nutrition	Other: standard infant formula Other: Test formula	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Standard infant formula	Other: standard infant formula standard infant formula given from 3 to 12 months of age, as per standard requirement
Experimental: 2 Test formula	Other: Test formula Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.
No Intervention: 3 Breastfeeding reference group

Arm

Intervention/Treatment

Placebo Comparator: 1

Standard infant formula

Other: standard infant formula

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

Experimental: 2

Test formula

Other: Test formula

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

No Intervention: 3

Breastfeeding reference group

Outcome Measures

Primary Outcome Measures

mean weight gain [3 months]

Secondary Outcome Measures

blood test assessments; body composition, bone density [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departamento de Medicina Interna, University de la Frontera	Temuco		Chile

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator: Jaime Inostroza, PhD, Universidad de La Frontera

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT00820833

Other Study ID Numbers:

05.29.INF

First Posted:

Jan 12, 2009

Last Update Posted:

Mar 26, 2015

Last Verified:

Dec 1, 2014

Keywords provided by Nestlé

infant formula

obesity

growth

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Mar 26, 2015