Clinical trial NCT03456934: Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease
Official title: Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Formula
Growth
Keywords: Protein requirements
Adiposity
Body composition
Cardiovascular health
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: University College, London
First posted: 2018-03-07
Enrollment: 249
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind with nonrandomized breast-fed reference group
Primary purpose: OTHER

Brief summary: The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.

Detailed description: Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.

Eligibility criteria: Inclusion Criteria:

* Healthy term infant
* Infant is aged 14 weeks (+/- 1 week)
* Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks

Exclusion Criteria:

* Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
* Infant born with congenital disease or malformation affecting growth and/or development
* Food allergy to any trial products (e.g. milk, soy)

Primary outcomes:
measure: Infant weight gain
timeFrame: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Secondary outcomes:
measure: Body mass index (BMI)-for-age Z-score
timeFrame: Age 2 years (+/- 1 month)
measure: Height-for-age Z-score
timeFrame: Age 2 years (+/- 1 month)
measure: Adiposity
timeFrame: Age 2 years (+/- 1 month)
measure: Fat mass
timeFrame: Age 2 years (+/- 1 month)
Other outcomes:
measure: Infant weight gain
timeFrame: Between 6 and 12 months
measure: Weight
timeFrame: Ages 4, 5, 6, 12 and 24 months
measure: Length or height
timeFrame: Ages 4, 5, 6, 12 and 24 months
measure: Head circumference
timeFrame: Ages 4, 5, 6, 12 and 24 months
measure: Body mass index
timeFrame: Ages 6, 12 and 24 months
measure: Weight-for-age Z-score
timeFrame: Ages 14 weeks and 4, 5, 6, 12 and 24 months
measure: Weight-for-length Z-score
timeFrame: Ages 14 weeks and 4, 5, 6, 12 and 24 months
measure: Height-for-age Z-score
timeFrame: Ages 14 weeks and 4, 5, 6, and 12 months
measure: BMI-for-age Z-score
timeFrame: Ages 14 weeks and 4, 5, 6, and 12 months
measure: Adverse events
timeFrame: Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months
measure: Feeding intake
timeFrame: Ages 14 weeks and 4, 5, 6, and 12 months
measure: Feeding tolerance
timeFrame: Ages 14 weeks and 4, 5, 6, and 12 months
measure: Metabolic markers of cardiovascular health
timeFrame: Ages 6 and 12 months
measure: Blood pressure
timeFrame: At age 12 and 24 months
measure: Appetite and feeding / eating behavior
timeFrame: Ages 14 weeks and 4, 5, 6, and 24 months
Locations:
city: London
country: United Kingdom
facility: UCL Institute of Child Health
Study officials:
affiliation: Childhood Nutrition Research Centre, University College London, Institute of Child Health
name: Atul Singhal, MD
role: PRINCIPAL_INVESTIGATOR
References: