Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease (BabyGrowth)

Nestlé

Status: Completed

Conditions: Infant Formula; Growth

Treatments: Other: Standard infant formula; Other: Modified infant formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03456934

15.09.INF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 13 to 15 weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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249 participants in 3 patient groups

Experimental Group

Experimental group

Description:

Modified infant formula given from 3 to 12 months of age, as per standard requirement.

Treatment:

Other: Modified infant formula

Control Group

Active Comparator group

Description:

Standard infant formula given from 3 to 12 months of age, as per standard requirement.

Treatment:

Other: Standard infant formula

Breast-fed Reference Group

No Intervention group

Description:

Non-randomized infants who are predominantly breast-fed at time of enrollment.