Infant DevelopmentCHOPNCT00338689
European Childhood Obesity Project: Early Programming by Infant Nutrition?
A study testing Lower protein formula; Higher protein formula in people with Infant Development, run by Ludwig-Maximilians - University of Munich at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Lower protein formula; Higher protein formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,678 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2002to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Belgium1 site
CHC St. Vincent, Liège / Universite Libre de Bruxelles
Liège, BE-4000
About this study
Official title: Childhood Obesity - Programming by Infant Nutrition
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.
Read the detailed description
Obesity has become a global epidemic and is a major health challenge for children and ado-lescents in industrialised countries, with a high and steadily increasing prevalence. Individual obesity risk is strongly influenced by genetic disposition and lifestyle factors. But in addition, there are clear indications that metabolic events during pre- and postnatal development mark-edly modulate obesity risk in later life, known as metabolic programming. Epidemiological studies and animal experiments suggest a causal relationship between nutrition early in life and the risk of later obesity, e.g. breast feeding seems to reduce the risk of obesity.
One factor clearly different between breast and formula fed infants is the protein intake, and thus in the Childhood Obesity Project the influence of this factor will be tested by feeding in double blind random-ised clinical trial two formulas with different protein content (7.3 % vs. 12 % of energy) to infants from five European countries (Belgium, Germany, Italy, Poland, Spain). Protein supply via formula is defined for the first year of life, while additional food is only recorded. Until the age of 2 years the growth and development of the infants is followed by frequent stand-ardised measurements and data on socio-economic status, parental attitudes and medical his-tory are collected. The available data will be evaluated in respect to the influence of protein intake and all the other factors on anthropometric markers for later obesity. This seems justi-fied as the weight and length growth until the age of 2 years have been shown to predict the body mass index with 14 years, suggesting that this is a suitable and very early indicator for overweight later in life.
Furthermore, differences between the participating countries will be studied with the aim to identify further environmental factors influencing obesity risk. On a long term base it is planned to follow the study participants via mailed questionnaires until the age of eight years to validate the risk estimators in a huge well defined population.
Primary objectives:
- To test the influence of the protein content of the infant formula fed during the first year of life on growth until the age of two years (main outcome measures: length and weight velocity).
- First year protein intake predicts later risk of childhood obesity ('Early protein hypothe-sis'). Primary outcome measure: BMI at the age of 8 years.
- Protein intake in the first year of life is associated to long-term metabolic outcomes: BMI and Body Composition at 18 years
Secondary objectives:
- Evaluation of the effects of different habitual protein intakes with traditional complemen-tary feeding regimes in infants in 5 European countries.
- Examination of the relationship between different types of infant feeding regimes with respect to Beikost on an early anthropometric markers of later obesity development.
- Investigation of effects of these infant feeding regimes on body composition, energy ex-penditure, protein metabolism, renal function and size, leptin and its binding protein and on IGF-1.
- Exploration of consumer attitudes and infant feeding practices in relation to parental obe-sity status.
- Investigation of the mediation of the relationship between diet and later growth via bio-chemical parameters, which might become detectable by the plasma concentrations of the corresponding compounds at the age of 6 months.
- Investigation of the effects of infant behaviour (esp. crying, sleeping and feeding behav-iour) on development of obesity.
- Comparison of the weight and length development to a non randomised cohort of breast-fed infants.
- Measurement of the effects of dietary regimes on body composition measured by stable dilution techniques (subgroup only).
- Measurement of the effects of dietary regimes on total energy expenditure and exploration of relationships between TEE, body composition and obesity risk (subgroup only).
- Conditions
- Infant Development
- Being tested
- Lower protein formula; Higher protein formula
- Keywords
- infant formula, protein content, growth, obesity, breast feeding
- Medical subject headings
- Obesity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower protein formula; Higher protein formulaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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" Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At age 11 years and 18 years
Secondary outcomes (5)
Dietary intake
3 day dietary protocols and food frequency questionnaires, (at 11and 18 years only EFPQ)
Measured: At 1-9,12,18 and 24 months, at 3, 4, 5, 6, 8, 11, 18 years
Blood parameters
Partially: Plasma amino acids, hormones, NEFAs, Polar-Lipids, triglycerides
Measured: At age 6 months, 5.5 years, 8 years, 11 and 18 years
Physical activity
Physical activity questionnaire and sensewear accelerometer data
Measured: At age 2, 4, 6, 8, 11 years (questionnaires), at 6, 8, 11, 18 years accelerometer
Body composition
Skinfold measurements at all time points, additionally bioelectrical impedance at 5, 5.5, 6, 7,8 11 and years, partly additionaly air displacement plethysmography at 18 years
Measured: at 3, 6, 12, 24 months, biannually from 3 to 6 years, at 7,8,11, 18 years
Urine markers
Uric acid, urea, creatinine, calcium secretion, C-peptide (not at 18 years)
Measured: At 6 months, 5.5, 8, 11 and 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startOct 2002
- Primary completionAug 2006
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Prof., Principal investigator, Ludwig-Maximilians-Universitaet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338689
- Sponsor's protocol ID
- 00389
- Acronym
- CHOP
- Status last verified
- Dec 2023
- First submitted
- 19 Jun 2006
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Aubert AM, Schipper MC, Guerlich K, Tafflet M, Lecorguille M, Yuan WL, Douglass A, McAuliffe FM, Grote V, Koletzko B, Ferre N, Escribano J, Luque V, Lioret S, Heude B, Gaillard R, Phillips CM. Maternal healthy lifestyle during pregnancy and offspring metabolic health phenotypes in childhood. Nutr Metab Cardiovasc Dis. 2026 Sep 2:104991. doi: 10.1016/j.numecd.2026.104991. Online ahead of print.
PubMed 42791115Triebswetter A, Erhardt J, Totzauer M, Luque V, Gispert-Llaurado M, Verduci E, Gruszfeld D, Xhonneux A, Koletzko B, Grote V. Mediterranean dietary pattern analysis combining two nutritional assessment tools in children aged 3 to 6 years in five European countries. Eur J Nutr. 2026 Apr 15;65(3):118. doi: 10.1007/s00394-026-03930-y.
PubMed 41984216Totzauer 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.
PubMed 36355369Jaeger 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.
PubMed 35930067Xhonneux 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.
PubMed 34982337Guerlich 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.
PubMed 33624130Aumueller 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.
PubMed 32377804Aumueller 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.
PubMed 31642983Schwarzfischer 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.
PubMed 30526600Schwarzfischer 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.
PubMed 30509928Totzauer 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.
PubMed 29932518Gomes 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.
PubMed 28780991Schwarzfischer 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.
PubMed 28645324Closa-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.
PubMed 28351509Zaragoza-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.
PubMed 28238467
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Obesity - Programming by Infant Nutrition
- ClinicalTrials.gov ID
- NCT00338689
- Acronym / sponsor ID
- CHOP / 00389
- Conditions
- Infant Development
- Keywords
- infant formula, protein content, growth, obesity, breast feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,678 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Oct 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity has become a global epidemic and is a major health challenge for children and ado-lescents in industrialised countries, with a high and steadily increasing prevalence. Individual obesity risk is strongly influenced by genetic disposition and lifestyle factors. But in addition, there are clear indications that metabolic events during pre- and postnatal development mark-edly modulate obesity risk in later life, known as metabolic programming. Epidemiological studies and animal experiments suggest a causal relationship between nutrition early in life and the risk of later obesity, e.g. breast feeding seems to reduce the risk of obesity.
One factor clearly different between breast and formula fed infants is the protein intake, and thus in the Childhood Obesity Project the influence of this factor will be tested by feeding in double blind random-ised clinical trial two formulas with different protein content (7.3 % vs. 12 % of energy) to infants from five European countries (Belgium, Germany, Italy, Poland, Spain). Protein supply via formula is defined for the first year of life, while additional food is only recorded. Until the age of 2 years the growth and development of the infants is followed by frequent stand-ardised measurements and data on socio-economic status, parental attitudes and medical his-tory are collected. The available data will be evaluated in respect to the influence of protein intake and all the other factors on anthropometric markers for later obesity. This seems justi-fied as the weight and length growth until the age of 2 years have been shown to predict the body mass index with 14 years, suggesting that this is a suitable and very early indicator for overweight later in life.
Furthermore, differences between the participating countries will be studied with the aim to identify further environmental factors influencing obesity risk. On a long term base it is planned to follow the study participants via mailed questionnaires until the age of eight years to validate the risk estimators in a huge well defined population.
Primary objectives:
- To test the influence of the protein content of the infant formula fed during the first year of life on growth until the age of two years (main outcome measures: length and weight velocity).
- First year protein intake predicts later risk of childhood obesity ('Early protein hypothe-sis'). Primary outcome measure: BMI at the age of 8 years.
- Protein intake in the first year of life is associated to long-term metabolic outcomes: BMI and Body Composition at 18 years
Secondary objectives:
- Evaluation of the effects of different habitual protein intakes with traditional complemen-tary feeding regimes in infants in 5 European countries.
- Examination of the relationship between different types of infant feeding regimes with respect to Beikost on an early anthropometric markers of later obesity development.
- Investigation of effects of these infant feeding regimes on body composition, energy ex-penditure, protein metabolism, renal function and size, leptin and its binding protein and on IGF-1.
- Exploration of consumer attitudes and infant feeding practices in relation to parental obe-sity status.
- Investigation of the mediation of the relationship between diet and later growth via bio-chemical parameters, which might become detectable by the plasma concentrations of the corresponding compounds at the age of 6 months.
- Investigation of the effects of infant behaviour (esp. crying, sleeping and feeding behav-iour) on development of obesity.
- Comparison of the weight and length development to a non randomised cohort of breast-fed infants.
- Measurement of the effects of dietary regimes on body composition measured by stable dilution techniques (subgroup only).
- Measurement of the effects of dietary regimes on total energy expenditure and exploration of relationships between TEE, body composition and obesity risk (subgroup only).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lower protein formula | Experimental | Dietary Supplement: Lower protein formula; Higher protein formulaIntervention: Infant formula with relatively low protein content (1.25 g/ 100 ml) during the first year of life; described as "Lower protein formula" |
| Higher protein formula | Placebo comparator | Dietary Supplement: Lower protein formula; Higher protein formulaIntervention: Infant formula with a relatively high protein content (2.05 g/ 100 ml) during the first year of life; described as "Higher protein formula" |
| Breastfed reference group | No intervention | –Non-randomized breastfed group of infants at least 3 months exclusively breastfed |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower protein formula; Higher protein formulaDuring 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. | Dietary supplement | Higher protein formula, Lower protein formula |
Primary outcome
Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height²
Time frame: At age 11 years and 18 years
Body height (cm) will be determined with calibrated clinical equipment Body weight (kg) will be determined with calibrated clinical equipment BMI calculated
5 secondary outcomes
Dietary intake
Time frame: At 1-9,12,18 and 24 months, at 3, 4, 5, 6, 8, 11, 18 years
Blood parameters
Time frame: At age 6 months, 5.5 years, 8 years, 11 and 18 years
Physical activity
Time frame: At age 2, 4, 6, 8, 11 years (questionnaires), at 6, 8, 11, 18 years accelerometer
Body composition
Time frame: at 3, 6, 12, 24 months, biannually from 3 to 6 years, at 7,8,11, 18 years
Urine markers
Time frame: At 6 months, 5.5, 8, 11 and 18 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 42791115Aubert AM, Schipper MC, Guerlich K, Tafflet M, Lecorguille M, Yuan WL, Douglass A, McAuliffe FM, Grote V, Koletzko B, Ferre N, Escribano J, Luque V, Lioret S, Heude B, Gaillard R, Phillips CM. Maternal healthy lifestyle during pregnancy and offspring metabolic health phenotypes in childhood. Nutr Metab Cardiovasc Dis. 2026 Sep 2:104991. doi: 10.1016/j.numecd.2026.104991. Online ahead of print.
- Derived from this study: PubMed 41984216Triebswetter A, Erhardt J, Totzauer M, Luque V, Gispert-Llaurado M, Verduci E, Gruszfeld D, Xhonneux A, Koletzko B, Grote V. Mediterranean dietary pattern analysis combining two nutritional assessment tools in children aged 3 to 6 years in five European countries. Eur J Nutr. 2026 Apr 15;65(3):118. doi: 10.1007/s00394-026-03930-y.
- Derived from this study: PubMed 36355369Totzauer 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.
- Derived from this study: PubMed 35930067Jaeger 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.
- Derived from this study: PubMed 34982337Xhonneux 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.
- Derived from this study: PubMed 33624130Guerlich 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.
- Derived from this study: PubMed 32377804Aumueller 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.
- Derived from this study: PubMed 31642983Aumueller 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.
- Derived from this study: PubMed 30526600Schwarzfischer 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.
- Derived from this study: PubMed 30509928Schwarzfischer 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.
- Derived from this study: PubMed 29932518Totzauer 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.
- Derived from this study: PubMed 28780991Gomes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Koletzko, Prof. principal investigator
Ludwig-Maximilians-Universitaet
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower protein formula; Higher protein formula in people with Infant Development, run by Ludwig-Maximilians - University of Munich at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, Italy, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (time frame: At age 11 years and 18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00338689, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.