Evidence map›Paper›PMID 25373935›Full record

Trial reportNutrition journal2014

Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial.

Joyce Nowacki, Hung-Chang Lee, Reyin Lien, Shao-Wen Cheng, Sung-Tse Li, Manjiang Yao, Robert Northington, Ingrid Jan, Gisella Mutungi

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
1.9field-weighted citation impact, top 16% 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.

NCT02031003 nacompletednot on this map

Effect of an Infant Formula With High 2-Palmitic Vegetable Oil or an Identical Formula Supplemented With Oligofructose on Stool Composition and Stool Characteristics in Healthy Term Infants in Taiwan

TypeinterventionalSponsorSociété des Produits Nestlé (SPN)Ran2010 to 2011Enrolled220ConditionsBottle FeedingArmsInfant formula
NCT03488758 nacompletednot on this mapstarted 2018, after this paper: background citation

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

TypeinterventionalSponsorCentre Hospitalier Intercommunal CreteilRan2018 to 2021Enrolled73ConditionsFeeding Behavior, Feeding, BottleArmsCMF, GMF
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 84 citations in OpenAlex.

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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

9 authors at 3 institutions in 2 countries.

Joyce Nowacki
Hung-Chang Lee
Reyin Lien
Shao-Wen Cheng
Sung-Tse Li
Manjiang Yao
Robert Northington
Ingrid Jan
Gisella MutungiNestlé Nutrition, 3000 Horizon Drive, King of Prussia, PA 19406, USA. Gisella.Mutungi@rd.nestle.com.
Nestlé (United States) · USChang Gung Memorial Hospital · TWMackay Memorial Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFormula-fed (FF) infants often have harder stools and higher stool concentrations of fatty acid soaps compared to breastfed infants. Feeding high sn-2 palmitate or the prebiotic oligofructose (OF) may soften stools, reduce stool soaps, and decrease fecal calcium loss.

methodsWe investigated the effect of high sn-2 palmitate alone and in combination with OF on stool palmitate soap, total soap and calcium concentrations, stool consistency, gastrointestinal (GI) tolerance, anthropometrics, and hydration in FF infants. This double-blind trial randomized 165 healthy term infants 25-45 days old to receive Control formula (n = 54), formula containing high sn-2 palmitate (sn-2; n = 56), or formula containing high sn-2 palmitate plus 3 g/L OF (sn-2+OF; n = 55). A non-randomized human milk (HM)-fed group was also included (n = 55). The primary endpoint, stool composition, was determined after 28 days of feeding, and was assessed using ANOVA accompanied by pairwise comparisons. Stool consistency, GI tolerance and hydration were assessed at baseline, day 14 (GI tolerance only) and day 28.

resultsInfants fed sn-2 had lower stool palmitate soaps compared to Control (P = 0.0028); while those fed sn-2+OF had reduced stool palmitate soaps compared to both Control and sn-2 (both P < 0.0001). Stool total soaps and calcium were lower in the sn-2+OF group than either Control (P < 0.0001) or sn-2 (P < 0.0001). The HM-fed group had lower stool palmitate soaps, total soaps and calcium (P < 0.0001 for each comparison) than all FF groups. The stool consistency score of the sn-2+OF group was lower than Control and sn-2 (P < 0.0001), but higher than the HM-fed group (P < 0.0001). GI tolerance was similar and anthropometric z-scores were <0.2 SD from the WHO growth standards in all groups, while urinary hydration markers were within normal range for all FF infants.

conclusionsIncreasing sn-2 palmitate in infant formula reduces stool palmitate soaps. A combination of high sn-2 palmitate and OF reduces stool palmitate soaps, total soaps and calcium, while promoting softer stools.

trial registrationThis study was registered on http://www.clinicaltrials.gov: number NCT02031003.

Indexed as

Breast FeedingCalcium, DietaryDouble-Blind MethodFatty AcidsFecesFemaleGastrointestinal TractHumansInfant FormulaInfant, NewbornMaleMilk, HumanOligosaccharidesPalmitatesPrebioticsTreatment OutcomeCalcium, DietaryFatty AcidsoligofructoseOligosaccharidesPalmitatesPrebiotics

Identifiers

PMID25373935
PMCPMC4273321
OpenAlexW2102153351

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.