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Toddler Milk Intervention Trial (TOMI)

This study is currently recruiting participants.
Verified October 2017 by Nestlé
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907502
First Posted: September 20, 2016
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life

Condition Intervention
Healthy Dietary Supplement: Young-child formula with low protein content Dietary Supplement: Young-child formula with protein content similar to that of cow's milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • BMI-for-age z-score at the age of 24 months [ Time Frame: Age 24 months ]

Secondary Outcome Measures:
  • Growth parameters: Anthropometry: Weight, Length, Heel knee length, Mid-arm circumference, Waist circumference, Hip circumference (only 48 months and 72 months), Head circumference, Triceps skinfold, Subscapular skinfold [ Time Frame: Age 12, 18, 24, 48 and 72 months ]
  • Child's development: Parental rating of child development with Ages & Stages Questionnaires® [ Time Frame: Age 24 and 48 months ]
  • Body composition: air displacement plethysmography [ Time Frame: at 24, 48 and 72 months of age ]
  • Metabolic and endocrine markers: Blood and Urine markers [ Time Frame: Age 12, 24 and 72 months ]
    Blood: Complete blood count, Glucose, Creatinine, Ferritin (measured only at 24 months), 25-OH vitamin D (measured only at 24 months), Triglycerides, Total cholesterol, HDL- and LDL-cholesterol, Insulin, IGF-1, IGF-BP2, IGF-BP3, Leptin, Adiponectin, Ghrelin, Amino Acids, Serum albumin, Urea, C-reactive protein, Osteocalcin / Urine: Calcium, C-peptide, Creatinine, Urea nitrogen

  • Metabolomic profile: Plasma and urine metabolic indicators of energy and protein metabolism (metabolomics with a focus on carnitines, amino acid catabolism, ketone bodies, Krebs cycle, and bacterial utilization of protein and carbohydrates) [ Time Frame: Age 12, 18, 24, 48 and 72 months ]
  • DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites) [ Time Frame: Age 12, 24 and 72 months ]
  • Blood pressure [ Time Frame: Age 48 and 72 months ]
  • Dietary intake: 24-hour recall [ Time Frame: Age 12, 18, 24, 48 and 72 months ]

Estimated Enrollment: 1618
Study Start Date: September 2016
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental formula
Young-child formula with low protein content
Dietary Supplement: Young-child formula with low protein content
Young-child formula with low protein content
Active Comparator: Control formula
Young-child formula with protein content similar to that of cow's milk
Dietary Supplement: Young-child formula with protein content similar to that of cow's milk
Young-child formula with protein content similar to that of cow's milk

Detailed Description:
This study is designed to investigate in a randomized double-blind parallel-group trial the growth and metabolic effects of different contributions of protein to total energy intakes in healthy children during the second year of life
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having obtained his/her parents' (or his/her legally accepted representative [LAR's] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
  • Child was born full term (≥ 37 weeks of gestation)
  • Age at enrollment: between 11.5 months and 13.5 months of age
  • 2.5 kg ≤ birth weight ≤ 4.5 kg
  • Born from a singleton pregnancy
  • Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

  • Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
  • Cows' milk allergy
  • Lactose intolerance
  • Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
  • Infant who is being breastfed at the time of enrollment
  • Infant who does not usually drink 300ml of cow's and/or formula milk per day
  • Institutionalized children
  • Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
  Contacts and Locations
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): NCT02907502


Contacts
Contact: Berthold Koletzko, Professor +49 (0) 89 44005 2826 berthold.koletzko@med.uni-muenchen.de

Locations
Germany
Dr Von Hauner Children's hospital Recruiting
Munich, Germany, 80337
Principal Investigator: Berthold Koletzko, Professor         
Spain
Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili. Recruiting
Tarragona, Spain
Principal Investigator: Ricardo Closa-Monasterolo, Professor         
Principal Investigator: Joaquín Escribano, Professor         
Sponsors and Collaborators
Nestlé
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02907502     History of Changes
Other Study ID Numbers: 13.29.INF
First Submitted: August 31, 2016
First Posted: September 20, 2016
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No