- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907502
Toddler Milk Intervention Trial (TOMI)
October 2, 2023 updated by: Société des Produits Nestlé (SPN)
Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial
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
Study Overview
Status
Active, not recruiting
Conditions
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
Study Type
Interventional
Enrollment (Estimated)
1618
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental formula
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
|
Young-child formula with protein content similar to that of cow's milk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI-for-age z-score
Time Frame: Age 24 months
|
WHO-growth standard
|
Age 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI-for-age z-score
Time Frame: Age 72 months
|
Age 72 months
|
|
The percentage of overweight and obese children
Time Frame: Age 24 months
|
CDC definition: Overweight above 85th to less than the 95th percentile and obese 95th percentile or greater and analyzed by the method of Peacock (Dichotomising continuous data while retaining statistical power using a distributional approach, Statistics in medicine, 2012).
|
Age 24 months
|
The percentage of overweight and obese children
Time Frame: Age 72 months
|
Age 72 months
|
|
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
|
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
|
Age 24 and 48 months
|
|
Body composition: air displacement plethysmography
Time Frame: at 24, 48 and 72 months of age
|
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
|
Age 12, 24 and 72 months
|
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
|
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
|
Age 12, 24 and 72 months
|
|
Blood pressure
Time Frame: Age 48 and 72 months
|
Age 48 and 72 months
|
|
Dietary intake: 24-hour recall
Time Frame: Age 12, 18, 24, 48 and 72 months
|
Age 12, 18, 24, 48 and 72 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
July 1, 2021
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 31, 2016
First Submitted That Met QC Criteria
September 14, 2016
First Posted (Estimated)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 13.29.INF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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