Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition

NCT ID: NCT02282488

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-12-31

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.

Detailed Description

The primary objective of this clinical trial is to show that infants taking (from birth) either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at 4 months, 25% lower to the IGF-1 measured in infants that received a high protein content formula (HiF).

The secondary objectives are: The hormonal profile; the Fat mass (FM) gain and the Lean mass (LM); the metabolomics and aminogramm during the first year of life.

Subjects are included in the study for a duration of 5 years. From birth to 4 months they are exclusively fed BF or FF. From 4 months of age they can start diversification, but they maintain the starter formulas until 12 months (the BF group will receive LoF). Subjects are then followed up until 5 years of age.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: Low protein formula

Low protein formula

Group Type: EXPERIMENTAL

Low protein formula

Intervention Type: OTHER

Group 2: high protein formula

High protein formula

Group Type: EXPERIMENTAL

High protein formula

Intervention Type: OTHER

Group Breastfeeding

Breastfeeding

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low protein formula

Intervention Type: OTHER

High protein formula

Intervention Type: OTHER

Other Intervention Names

LoF; HiF

Eligibility Criteria

Inclusion Criteria

. 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Steenhout, MD

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Locations

Hôpital de la Croix-Rouse

Lyon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37929831 (View on PubMed)

Other Identifiers

05.14.INF

Identifier Type: -

Identifier Source: org_study_id