Toddler Milk Intervention Trial

Healthy Clinical Trial

Official title:

Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02907502
• Other study ID #: 13.29.INF
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1618
• Est. completion date: December 2026
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Months to 13 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Young-child formula with low protein content
Young-child formula with low protein content
• 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

Locations

Country	Name	City	State
Germany	Dr Von Hauner Children's hospital	Munich
Spain	Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili.	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI-for-age z-score	WHO-growth standard	Age 24 months
Secondary	BMI-for-age z-score		Age 72 months
Secondary	The percentage of overweight and obese children	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
Secondary	The percentage of overweight and obese children		Age 72 months
Secondary	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		Age 12, 18, 24, 48 and 72 months
Secondary	Child's development: Parental rating of child development with Ages & Stages Questionnaires®		Age 24 and 48 months
Secondary	Body composition: air displacement plethysmography		at 24, 48 and 72 months of age
Secondary	Metabolic and endocrine markers: Blood and Urine markers	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
Secondary	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)		Age 12, 18, 24, 48 and 72 months
Secondary	DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites)		Age 12, 24 and 72 months
Secondary	Blood pressure		Age 48 and 72 months
Secondary	Dietary intake: 24-hour recall		Age 12, 18, 24, 48 and 72 months