Trial reportBMC pediatrics2018
Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.
Trial report in BMC pediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03035721 (Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Higher versus lower protein intake in formula-fed term infants.The Cochrane database of systematic reviews · 2023Pooled it
- Protein and growth during the first year of life: a systematic review and meta-analysis.Pediatric research · 2023Pooled it
- The Association of Formula Protein Content and Growth in Early Infancy: A Systematic Review and Meta-Analysis.Nutrients · 2022Pooled it
- Lower Protein Intake Supports Normal Growth of Full-Term Infants Fed Formula: A Randomized Controlled Trial.Nutrients · 2018Trial
- Food and Drug Administration Expert Panel on Infant Formula "Operation Stork Speed" June 2025: Part 1, Nutrient Considerations.Advances in nutrition (Bethesda, Md.) · 2026Review
- A Scoping Review of Instruments Used to Measure Weight and Body Composition in Infants Under 1 Year.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026Article
- Systematic Search of Height and Weight Changes of Exclusively Breastfed Infants Until 1 Year of age: A Contribution from the ConcePTION Project.Clinical pharmacokinetics · 2025Review
- A Microfluidic Approach for Profiling Total Nitrogen Content in Age-Specific Nutritional Formulas Using Microchip Gel Electrophoresis.International journal of molecular sciences · 2025Article
- A review of recent evidence of dietary protein intake and health.Nutrition research and practice · 2022Review
- Correction to: Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.BMC pediatrics · 2018Article
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA high early protein intake is associated with rapid postnatal weight gain and altered body composition. We aimed to evaluate the safety of a low-protein formula in healthy full-term infants.
methodsA randomized controlled trial was conducted. A total of 118 infants were randomized to receive two different protein content formulas (formula A or formula B (protein content: 1.2 vs. 1.7 g/100 mL, respectively)) for the first 4 months of life. Anthropometry and body composition by air displacement plethysmography were assessed at enrolment and at two and 4 months. The reference group comprised 50 healthy, exclusively breastfed, full-term infants.
resultsWeight gain (g/day) throughout the study was similar between the formula groups (32.5 ± 6.1 vs. 32.8 ± 6.8) and in the reference group (30.4 ± 5.4). The formula groups showed similar body composition but a different fat-free mass content from breastfed infants at two and 4 months. However, the formula A group showed a fat-free mass increase more similar to that of the breastfed infants. The occurrence of gastrointestinal symptoms or adverse events was similar between the formula groups.
conclusionsFeeding a low-protein content formula appears to be safe and to promote adequate growth, although determination of the long-term effect on body composition requires further study.
trial registrationThe present study was retrospectively registered in ClinicalTrials.gov (trial number: NCT03035721 on January 18, 2017).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.