Nutritive Efficacy and Safety of a Modified Infant Formula With a Reduced Protein Content and Improved Protein Quality

NCT02469402 | Completed

• 1 other identifier: 1026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Formula contains significantly higher total protein concentrations than breast milk. Therefore formula-fed infants have a significantly higher total protein intake in the first few months compared to exclusively breast-fed infants. The aim is to examine the nutritive efficacy and safety of a modified infant formula with a reduced protein content and improved protein quality in a prospective, double-blind, controled, randomized study. Primary outcome measures are weight gain and growth of young infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the qualitative and quantitative changes in the protein content of the new formula will be recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group will be fed for 3 months with an infant formula with decreased protein content. At the same time the protein body of the new formula is modified by enrichment with bovine alpha-lactalbumin. A control group receives a isocaloric conventional infant formula and a protein body consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of alpha-lactalbumin over the same time-period. A group of breastmilk fed infants will serve as a reference group. In regular anthropometric controls growth and thriving of the study participants is documented and compared between the different groups.

Conditions

Overweight

Keywords

reduced; protein; formula; Alpha-lactalbumin; infant

Outcome Measures

Primary Outcomes (1)

• Composite measure of Growth

  height, body weight, head circumference

  1 year

Secondary Outcomes (1)

• Daily fluid intake

  3 months

Other Outcomes (2)

• Plasma concentrations of transthyretin, urea and total protein

  3 months

• Body Fat Percentage

  1 year

Study Arms (3)

Standard infant formula

ACTIVE COMPARATOR

Standard infant formula

Dietary Supplement: Standard infant formula

Protein reduced formula

EXPERIMENTAL

Protein reduced alpha-lactalbumin formula

Dietary Supplement: Protein reduced alpha-lactalbumin formula, with higher levels of alpha-lactalbumin

Breast-feeding

NO INTERVENTION

Exclusive breast-feeding

Interventions

Standard infant formula DIETARY_SUPPLEMENT

Standard infant formula

Protein reduced alpha-lactalbumin formula, with higher levels of alpha-lactalbumin DIETARY_SUPPLEMENT

Protein reduced formula

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At the time of study enrollment apparently healthy newborns / infants without pronounced hyper- or hypotrophy (age-appropriate weight percentiles \> 3 and \< 97 according to Voigt et al.)
• Maternal decision against breastfeeding (for Formula Groups)

You may not qualify if:

• Congenital gastrointestinal malformations, metabolic disease, chromosomal aberration, syndromic disease with significant impact on growth, development, nutrition, immune competence
• Manifestation of a serious disease, which is expected to be accompanied by growth retardation, intestinal transit disruption or the need for special dietary treatment (e.g. hypertrophic pyloric stenosis, cystic fibrosis, Hirschsprung's disease, cow's milk protein intolerance.)
• Decision to administer HA (hypoallergenic) formula due to family atopies (defined by atopic disease of at least one 1 st degree relative: bronchial asthma, atopic dermatitis, pollinosis)
• Participation in another nutritional study

Sponsors & Collaborators

• Waldkrankenhaus Protestant Hospital, Spandau: lead
• Humana Inc.: collaborator

Study Sites (1)

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

Related Publications (2)

• von Kries R, Koletzko B, Sauerwald T, von Mutius E, Barnert D, Grunert V, von Voss H. Breast feeding and obesity: cross sectional study. BMJ. 1999 Jul 17;319(7203):147-50. doi: 10.1136/bmj.319.7203.147.

  PMID: 10406746 BACKGROUND

• 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: 37929831 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Jochum, Dr. med.

  Paul Gerhard Diakonie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hanna Petersen

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: January 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

DE (1)