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Trial record 1 of 1 for:    NCT00338689
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European Childhood Obesity Project: Early Programming by Infant Nutrition? (CHOP)

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ClinicalTrials.gov Identifier: NCT00338689
Recruitment Status : Active, not recruiting
First Posted : June 20, 2006
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

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 11 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.

Condition or disease Intervention/treatment Phase
Infant Development Dietary Supplement: Lower protein formula; Higher protein formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Childhood Obesity - Programming by Infant Nutrition
Study Start Date : October 2002
Actual Primary Completion Date : August 2006
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lower protein formula
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
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.

Placebo Comparator: Higher protein formula
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
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.

No Intervention: Breastfed reference group
Non-randomized breastfed group of infants at least 3 months exclusively breastfed



Primary Outcome Measures :
  1. Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² [ Time Frame: At age 11 years ]
    Body height (cm) will be determined with calibrated clinical equipment Body weight (kg) will be determined with calibrated clinical equipment BMI calculated


Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: At 1-9,12,18 and 24 months, at 3, 4, 5, 6, 8, 11 years ]
    3 day dietary protocols and food frequency questionnaires, (at 11 years only EFPQ)

  2. Blood parameters [ Time Frame: At age 6 months, 5.5 years, 8 years and 11 years ]
    Partially: Plasma amino acids, hormones, NEFAs, Polar-Lipids, triglycerides

  3. Physical activity [ Time Frame: At age 2, 4, 6, 8, 11 years (questionnaires), at 6, 8, 11 years accelerometer ]
    Physical activity questionnaire and sensewear accelerometer data

  4. Body composition [ Time Frame: at 3, 6, 12, 24 months, biannually from 3 to 6 years, at 7,8,11 years ]
    Skinfold measurements at all time points, additionally bioelectrical impedance at 5, 5.5, 6, 7,8 and 11 years

  5. Urine markers [ Time Frame: At 6 months, 5.5, 8 and 11 years ]
    Uric acid, urea, creatinine, calcium secretion, C-peptide



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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338689


Locations
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Belgium
CHC St. Vincent, Liège / Universite Libre de Bruxelles
Liège, Belgium, BE-4000
Germany
Ludwig-Maximilians-Universitaet
Muenchen, Germany, D 80337
Italy
Universita degli Studi di Milano
Milan, Italy, I-20122
Poland
Children´s Memorial Healzj Institute
Warsaw, Poland, P 04736
Spain
Universitat Rovira i Virgili
Tarragona, Spain, S 43003
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
European Union
Investigators
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Principal Investigator: Berthold Koletzko, Prof. Ludwig-Maximilians-Universitaet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Berthold Koletzko, Prof. Dr. Dr., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00338689    
Other Study ID Numbers: 00389
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Keywords provided by Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich:
infant formula
protein content
growth
obesity
breast feeding
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight