NCT02282488

Brief Summary

A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

October 24, 2014

Last Update Submit

October 31, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Analysis of IGF-1 value

    Analyse the IGF-1 value and compare it

    4 months

Secondary Outcomes (3)

  • Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1)

    2 weeks, 4 months and 12 months

  • DEXA scan as a measure of the body composition

    2 weeks, 4 months and 12 months

  • aminogramm analysis

    2 weeks, 4 months and 12 months

Study Arms (3)

Group 1: Low protein formula

EXPERIMENTAL

Low protein formula

Other: Low protein formula

Group 2: high protein formula

EXPERIMENTAL

High protein formula

Other: High protein formula

Group Breastfeeding

NO INTERVENTION

Breastfeeding

Interventions

Low protein formulaOTHER
Also known as: LoF
Group 1: Low protein formula
High protein formulaOTHER
Also known as: HiF
Group 2: high protein formula

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborn infant
  • Full term infant (= 37 weeks gestation; = 42 weeks gestation)
  • Birth weight = 2500 g and \< 4200 g
  • Singleton birth
  • Infant is = 7 days of age at the time of enrollment
  • For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
  • Having obtained his/her or his/her legal representative's consent

You may not qualify if:

  • Newborn whose mother's BMI was normal (\<20 or = 25) at start of pregnancy
  • Newborn whose mother had developed gestational diabetes during pregnancy
  • Newborn whose mother has diabetes of type-1 or type-2
  • Newborn whose mother smoked \> 5 cigarettes / day during pregnancy
  • Newborn whose mother had a drug dependence during pregnancy
  • Newborn whose mother has a chronic infectious disease
  • Newborn whose parents / caregivers cannot be expected to comply with treatment
  • Newborn currently participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix-Rouse

Lyon, 69317, France

Location

Related Publications (1)

  • 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.

    PMID: 37929831DERIVED

Study Officials

  • Philippe Steenhout, MD

    Société des Produits Nestlé (SPN)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

November 4, 2014

Study Start

April 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2012

Last Updated

November 4, 2014

Record last verified: 2014-10

Locations

FR(1)