Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Safety Issues; Infant Nutrition Disorders

Treatments: Dietary Supplement: Low protein formula; Dietary Supplement: Standard protein formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03035721

Low protein formula_RCT

Details and patient eligibility

About

This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.

Full description

Infants were randomized to receive either a standard protein formula or a low-protein formula. The composition of the low-protein formula vs the standard formula was: energy (65 vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).

To investigate the safety of the low-protein formula without any bias, a 4-month intervention period was selected during which the infants were fed only formula.

Anthropometric parameters (weight, length, and head circumference) and body composition were assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.

The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term infants.

Enrollment: 150 patients

Sex: All

Ages: 1 day to 3 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy
• singleton
• full-term infants (gestational age 37/0 to 41/6 weeks)
• birth weight adequate for gestational age (>p10 and <p90 for gestational age) according to the World Health Organization growth charts.

Exclusion criteria

• presence of congenital diseases
• presence of chromosomal abnormalities
• presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
• being born to mother affected by endocrine and/or metabolic diseases
• having a family history of allergic disease

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Low protein formula group

Experimental group

Description:

Full term healthy infants randomized to receive a low protein formula for the first 4 months of life

Treatment:

Dietary Supplement: Low protein formula

Standard protein formula group

Active Comparator group

Description:

Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life

Treatment:

Dietary Supplement: Standard protein formula

Breastfeeding group

No Intervention group

Description:

Breastfed full term healthy infants