Evidence map›Paper›PMID 34445029›Full record

ArticleNutrients2021

Evaluation of an Infant Formula with Large, Milk-Phospholipid Coated Lipid Droplets on Long-Term Growth and Development of Singaporean Infants: Randomized Controlled Trial Protocol.

Lynette P Shek, Yap Seng Chong, Antoinette Winokan, Marieke Abrahamse-Berkeveld, Eline M Van Der Beek, Oon Hoe Teoh, On Behalf Of The Venus Working Group

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Nutrients, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 26% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Lynette P ShekSingapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore 119228, Singapore.
Yap Seng ChongSingapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore 119228, Singapore.
Antoinette WinokanNutricia Research, Singapore 138671, Singapore.
Marieke Abrahamse-BerkeveldDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.ORCID 0000-0002-1899-2824
Eline M Van Der BeekDepartment of Paediatrics, University Medical Center Groningen, University of Groningen, 9700 RB Groningen, The Netherlands.
Oon Hoe TeohDepartment of Paediatrics, KK Women's and Children's Hospital, Singapore 229899, Singapore.
On Behalf Of The Venus Working Group
Agency for Science, Technology and Research · SGDanone (Netherlands) · NLKK Women's and Children's Hospital · SGUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A concept infant formula (IF) was developed with physical properties of lipid droplets mimicking more closely those in human milk. This paper describes the unique design of a randomised controlled trial evaluating the impact of the concept IF on infant growth and body composition development whilst applying a cohort-like recruitment approach that fully supports breastfeeding practices of the study population. Subjects entered the study between birth and 1 months of age, and whenever parents decided to introduce formula were randomised to one of three study formulas; the concept IF comprising large lipid droplets coated by milk phospholipids and containing a specific mixture of prebiotics, a standard IF with the specific prebiotic mixture or a standard IF without the prebiotic mixture. The primary objective was to evaluate the impact of the concept IF on growth and body composition outcomes during the first year of life with a follow-up at 2, 3, 4 and 5 years of age. In addition, stool, saliva and buccal smear samples and parameters assessing safety, gastrointestinal tolerance and cognitive outcomes were collected. The applied cohort-like enrolment approach is distinctly different from standard clinical safety or efficacy studies and may provide valuable insights on trial design for the evaluation of IF while carefully considering breastfeeding practices.

Indexed as

Bottle FeedingChild DevelopmentInfant FormulaLipid DropletsMilkNutritive ValueAge FactorsAnimalsBody CompositionBody HeightBody Mass IndexChild, PreschoolDouble-Blind MethodHumansInfantInfant, NewbornPhospholipidsPrebioticsbody composition developmentcohort-based recruitmentinfant growthlipid droplet structurerandomized controlled trialsafety

Identifiers

PMID34445029
PMCPMC8401090
OpenAlexW3195211463

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.