European Childhood Obesity Project: Early Programming by Infant Nutrition?

NCT00338689 | Unknown

• 1 other identifier: 00389
• Study Type: interventional
• Target: 1,678
• Locations: 5 countries
• Sites: 5

Brief Summary

Primary hypothesis to be tested: Early protein intake predicts infant growth and later risk of childhood obesity.

• Childhood obesity is a major public health problem and is an identified priority concern for the health care. Infants fed formula are more likely to become obese than breastfed infants. The higher protein content of infant formulae, compared with breast milk, could be a causal factor.
• The study will in a multicentre intervention trial on newborn infants investigate whether feeding infant formulae, which differ in their level of milk proteins, can influence the risk of later childhood obesity. The trial will take place in five countries with different habitual total protein intakes to increase the range of protein intakes
• The investigators will study body composition, hormonal status, protein metabolism and anthropometric markers of childhood obesity. The whole cohort will be followed up until age 18 years, to assess the long term impact on the prevalence of obesity.
• The investigators will explore the impact of consumer (parental) attitudes to, and perceptions of, different practices of infant feeding in relation to infant behaviour (satisfaction, crying, sleep duration). This consumer science information will help improve the understanding of consumer (infants and parents) acceptance of and preference for foods that contribute to healthy diets.
• If a relationship between early dietary protein intake and later childhood obesity risk is confirmed, it offers possibilities for the prevention of obesity, for improving advice given to parents and for developing nutritionally improved dietary products for infants.

Conditions

Infant Development

Keywords

infant formula; protein content; growth; obesity; breast feeding

Outcome Measures

Primary Outcomes (1)

• Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height²

  Body height (cm) will be determined with calibrated clinical equipment Body weight (kg) will be determined with calibrated clinical equipment BMI calculated

  At age 11 years and 18 years

Secondary Outcomes (5)

• Dietary intake

  At 1-9,12,18 and 24 months, at 3, 4, 5, 6, 8, 11, 18 years

• Blood parameters

  At age 6 months, 5.5 years, 8 years, 11 and 18 years

• Physical activity

  At age 2, 4, 6, 8, 11 years (questionnaires), at 6, 8, 11, 18 years accelerometer

• Body composition

  at 3, 6, 12, 24 months, biannually from 3 to 6 years, at 7,8,11, 18 years

• Urine markers

  At 6 months, 5.5, 8, 11 and 18 years

Study Arms (3)

Lower protein formula

EXPERIMENTAL

Intervention: Infant formula with relatively low protein content (1.25 g/ 100 ml) during the first year of life; described as "Lower protein formula"

Dietary Supplement: Lower protein formula; Higher protein formula

Higher protein formula

PLACEBO COMPARATOR

Intervention: Infant formula with a relatively high protein content (2.05 g/ 100 ml) during the first year of life; described as "Higher protein formula"

Dietary Supplement: Lower protein formula; Higher protein formula

Breastfed reference group

NO INTERVENTION

Non-randomized breastfed group of infants at least 3 months exclusively breastfed

Interventions

Lower protein formula; Higher protein formula DIETARY_SUPPLEMENT

During the intervention phase of the study, which is from inclusion in the study (latest age 2 weeks) until age 12 months, two experimental infant formulae with different protein content are fed to the enrolled infants; Lower protein formula and Higher protein formula. Additional a breastfed observational group without any intervention is included.

Higher protein formula; Lower protein formula

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \> 37 weeks
• Appropriate for gestational age (above 10th percentile,Lubchenko)
• Age of the mother at least 18 years
• Singleton pregnancies
• Residence in the study area
• Maternal command of the language

You may not qualify if:

• Gestational diabetes
• Major malformations (of the child) which might interfere with nutrition or growth
• Hormonal or metabolic diseases of the mother or the child, drug addiction during pregnancy

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• European Union: collaborator

Study Sites (5)

CHC St. Vincent, Liège / Universite Libre de Bruxelles

Liège, BE-4000, Belgium

Location

Ludwig-Maximilians-Universitaet

München, D 80337, Germany

Location

Universita degli Studi di Milano

Milan, I-20122, Italy

Location

Children´s Memorial Healzj Institute

Warsaw, P 04736, Poland

Location

Universitat Rovira i Virgili

Tarragona, S 43003, Spain

Location

Related Publications (22)

• Totzauer M, Escribano J, Closa-Monasterolo R, Luque V, Verduci E, ReDionigi A, Langhendries JP, Martin F, Xhonneux A, Gruszfeld D, Socha P, Grote V, Koletzko B; European Childhood Obesity Trial Study Group. Different protein intake in the first year and its effects on adiposity rebound and obesity throughout childhood: 11 years follow-up of a randomized controlled trial. Pediatr Obes. 2022 Dec;17(12):e12961. doi: 10.1111/ijpo.12961. Epub 2022 Jul 25.

  PMID: 36355369 DERIVED

• Jaeger V, Koletzko B, Luque V, Ferre N, Gruszfeld D, Gradowska K, Verduci E, Zuccotti GV, Xhonneux A, Poncelet P, Grote V. Distribution of energy and macronutrient intakes across eating occasions in European children from 3 to 8 years of age: The EU Childhood Obesity Project Study. Eur J Nutr. 2023 Feb;62(1):165-174. doi: 10.1007/s00394-022-02944-6. Epub 2022 Aug 5.

  PMID: 35930067 DERIVED

• Xhonneux A, Langhendries JP, Martin F, Seidel L, Albert A, Dain E, Totzauer M, Grote V, Luque V, Closa-Monasterolo R, Dionigi AR, Verduci E, Gruszfeld D, Socha P, Koletzko B; European Childhood Obesity Trial Study group. Parental Perception of Body Weight Status of Their 8-year-old Children: Findings from the European CHOP Study. Matern Child Health J. 2022 Jun;26(6):1274-1282. doi: 10.1007/s10995-021-03334-w. Epub 2022 Jan 1.

  PMID: 34982337 DERIVED

• Guerlich K, Gruszfeld D, Czech-Kowalska J, Ferre N, Closa-Monasterolo R, Martin F, Poncelet P, Verduci E, Koletzko B, Grote V. Sleep duration and problem behaviour in 8-year-old children in the Childhood Obesity Project. Eur Child Adolesc Psychiatry. 2022 Mar;31(3):519-527. doi: 10.1007/s00787-021-01731-8. Epub 2021 Feb 24.

  PMID: 33624130 DERIVED

• Aumueller N, Gruszfeld D, Gradowska K, Escribano J, Ferre N, Martin F, Poncelet P, Verduci E, ReDionigi A, Koletzko B, Grote V. Influence of total sugar intake on metabolic blood markers at 8 years of age in the Childhood Obesity Project. Eur J Nutr. 2021 Feb;60(1):435-442. doi: 10.1007/s00394-020-02229-w. Epub 2020 May 6.

  PMID: 32377804 DERIVED

• Aumueller N, Gruszfeld D, Gradowska K, Escribano J, Ferre N, Rousseaux D, Hoyos J, Verduci E, ReDionigi A, Koletzko B, Grote V. Associations of sugar intake with anthropometrics in children from ages 2 until 8 years in the EU Childhood Obesity Project. Eur J Nutr. 2020 Sep;59(6):2593-2601. doi: 10.1007/s00394-019-02107-0. Epub 2019 Oct 23.

  PMID: 31642983 DERIVED

• Schwarzfischer P, Gruszfeld D, Socha P, Luque V, Closa-Monasterolo R, Rousseaux D, Moretti M, Mariani B, Verduci E, Koletzko B, Grote V. Longitudinal analysis of physical activity, sedentary behaviour and anthropometric measures from ages 6 to 11 years. Int J Behav Nutr Phys Act. 2018 Dec 7;15(1):126. doi: 10.1186/s12966-018-0756-3.

  PMID: 30526600 DERIVED

• Schwarzfischer P, Gruszfeld D, Stolarczyk A, Ferre N, Escribano J, Rousseaux D, Moretti M, Mariani B, Verduci E, Koletzko B, Grote V. Physical Activity and Sedentary Behavior From 6 to 11 Years. Pediatrics. 2019 Jan;143(1):e20180994. doi: 10.1542/peds.2018-0994. Epub 2018 Dec 3.

  PMID: 30509928 DERIVED

• Totzauer M, Luque V, Escribano J, Closa-Monasterolo R, Verduci E, ReDionigi A, Hoyos J, Langhendries JP, Gruszfeld D, Socha P, Koletzko B, Grote V; European Childhood Obesity Trial Study Group. Effect of Lower Versus Higher Protein Content in Infant Formula Through the First Year on Body Composition from 1 to 6 Years: Follow-Up of a Randomized Clinical Trial. Obesity (Silver Spring). 2018 Jul;26(7):1203-1210. doi: 10.1002/oby.22203.

  PMID: 29932518 DERIVED

• Gomes D, Luque V, Xhonneux A, Verduci E, Socha P, Koletzko B, Berger U, Grote V. A simple method for identification of misreporting of energy intake from infancy to school age: Results from a longitudinal study. Clin Nutr. 2018 Jun;37(3):1053-1060. doi: 10.1016/j.clnu.2017.05.003. Epub 2017 Jun 1.

  PMID: 28780991 DERIVED

• Schwarzfischer P, Weber M, Gruszfeld D, Socha P, Luque V, Escribano J, Xhonneux A, Verduci E, Mariani B, Koletzko B, Grote V. BMI and recommended levels of physical activity in school children. BMC Public Health. 2017 Jun 24;17(1):595. doi: 10.1186/s12889-017-4492-4.

  PMID: 28645324 DERIVED

• Closa-Monasterolo R, Zaragoza-Jordana M, Ferre N, Luque V, Grote V, Koletzko B, Verduci E, Vecchi F, Escribano J; Childhood Obesity Project Group. Adequate calcium intake during long periods improves bone mineral density in healthy children. Data from the Childhood Obesity Project. Clin Nutr. 2018 Jun;37(3):890-896. doi: 10.1016/j.clnu.2017.03.011. Epub 2017 Mar 16.

  PMID: 28351509 DERIVED

• Zaragoza-Jordana M, Closa-Monasterolo R, Luque V, Ferre N, Grote V, Koletzko B, Pawellek I, Verduci E, ReDionigi A, Socha J, Stolarczyk A, Poncelet P, Rousseaux D, Escribano J; Childhood Obesity Project Group. Micronutrient intake adequacy in children from birth to 8 years. Data from the Childhood Obesity Project. Clin Nutr. 2018 Apr;37(2):630-637. doi: 10.1016/j.clnu.2017.02.003. Epub 2017 Feb 9.

  PMID: 28238467 DERIVED

• Kirchberg FF, Harder U, Weber M, Grote V, Demmelmair H, Peissner W, Rzehak P, Xhonneux A, Carlier C, Ferre N, Escribano J, Verduci E, Socha P, Gruszfeld D, Koletzko B, Hellmuth C; European Childhood Obesity Trial Study Group. Dietary protein intake affects amino acid and acylcarnitine metabolism in infants aged 6 months. J Clin Endocrinol Metab. 2015 Jan;100(1):149-58. doi: 10.1210/jc.2014-3157.

  PMID: 25368978 DERIVED

• Weber M, Grote V, Closa-Monasterolo R, Escribano J, Langhendries JP, Dain E, Giovannini M, Verduci E, Gruszfeld D, Socha P, Koletzko B; European Childhood Obesity Trial Study Group. Lower protein content in infant formula reduces BMI and obesity risk at school age: follow-up of a randomized trial. Am J Clin Nutr. 2014 May;99(5):1041-51. doi: 10.3945/ajcn.113.064071. Epub 2014 Mar 12.

  PMID: 24622805 DERIVED

• Rzehak P, Grote V, Lattka E, Weber M, Gruszfeld D, Socha P, Closa-Monasterolo R, Escribano J, Giovannini M, Verduci E, Goyens P, Martin F, Langhendries JP, Demmelmair H, Klopp N, Illig T, Koletzko B; European Childhood Obesity Trial Study Group. Associations of IGF-1 gene variants and milk protein intake with IGF-I concentrations in infants at age 6 months - results from a randomized clinical trial. Growth Horm IGF Res. 2013 Oct;23(5):149-58. doi: 10.1016/j.ghir.2013.05.002. Epub 2013 Jun 22.

  PMID: 23800627 DERIVED

• Luque V, Escribano J, Grote V, Ferre N, Koletzko B, Gruszfeld D, Socha P, Langhendries JP, Goyens P, Closa-Monasterolo R; European Childhood Obesity Project. Does insulin-like growth factor-1 mediate protein-induced kidney growth in infants? A secondary analysis from a randomized controlled trial. Pediatr Res. 2013 Aug;74(2):223-9. doi: 10.1038/pr.2013.87. Epub 2013 May 24.

  PMID: 23708690 DERIVED

• Luque V, Escribano J, Mendez-Riera G, Schiess S, Koletzko B, Verduci E, Stolarczyk A, Martin F, Closa-Monasterolo R. Methodological approaches for dietary intake assessment in formula-fed infants. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):320-7. doi: 10.1097/MPG.0b013e3182779a60.

  PMID: 23443063 DERIVED

• Closa-Monasterolo R, Ferre N, Luque V, Zaragoza-Jordana M, Grote V, Weber M, Koletzko B, Socha P, Gruszfeld D, Janas R, Xhonneux A, Dain E, Scaglioni S, Escribano J; Childhood Obesity Project Study Group. Sex differences in the endocrine system in response to protein intake early in life. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1920S-1927S. doi: 10.3945/ajcn.110.001123. Epub 2011 Nov 16.

  PMID: 22089446 DERIVED

• Grote V, Schiess SA, Closa-Monasterolo R, Escribano J, Giovannini M, Scaglioni S, Stolarczyk A, Gruszfeld D, Hoyos J, Poncelet P, Xhonneux A, Langhendries JP, Koletzko B; European Childhood Obesity Trial Study Group. The introduction of solid food and growth in the first 2 y of life in formula-fed children: analysis of data from a European cohort study. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1785S-1793S. doi: 10.3945/ajcn.110.000810. Epub 2011 Sep 14.

  PMID: 21918213 DERIVED

• Socha P, Grote V, Gruszfeld D, Janas R, Demmelmair H, Closa-Monasterolo R, Subias JE, Scaglioni S, Verduci E, Dain E, Langhendries JP, Perrin E, Koletzko B; European Childhood Obesity Trial Study Group. Milk protein intake, the metabolic-endocrine response, and growth in infancy: data from a randomized clinical trial. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1776S-1784S. doi: 10.3945/ajcn.110.000596. Epub 2011 Aug 17.

  PMID: 21849603 DERIVED

• Koletzko B, von Kries R, Closa R, Escribano J, Scaglioni S, Giovannini M, Beyer J, Demmelmair H, Gruszfeld D, Dobrzanska A, Sengier A, Langhendries JP, Rolland Cachera MF, Grote V; European Childhood Obesity Trial Study Group. Lower protein in infant formula is associated with lower weight up to age 2 y: a randomized clinical trial. Am J Clin Nutr. 2009 Jun;89(6):1836-45. doi: 10.3945/ajcn.2008.27091. Epub 2009 Apr 22.

  PMID: 19386747 DERIVED

MeSH Terms

Conditions

Obesity; Breast Feeding

Condition Hierarchy (Ancestors)

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

Study Officials

• Berthold Koletzko, Prof.

  Ludwig-Maximilians-Universitaet

  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: Prof. Dr. Dr.

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 20, 2006
• Study Start: October 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: December 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

PL (1); IT (1); DE (1); ES (1); BE (1)