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

I

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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