Evidence map›Paper›PMID 31006811›Full record

SynthesisThe Journal of nutrition2019

A Meta-Analysis of 46 Studies Identified by the FDA Demonstrates that Soy Protein Decreases Circulating LDL and Total Cholesterol Concentrations in Adults.

Sonia Blanco Mejia, Mark Messina, Siying S Li, Effie Viguiliouk, Laura Chiavaroli, Tauseef A Khan, Korbua Srichaikul, Arash Mirrahimi, John L Sievenpiper, Penny Kris-Etherton and 1 more

Registry-linked trialOpen access · bronzeAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in The Journal of nutrition, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03468127 (A Meta-analysis of 46 Studies Identified by the FDA on the Effect of Soy Protein on Lipid Markers), which is not on this map. Cited by 68 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 9 pooled it
9.5field-weighted citation impact, top 1% 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.

NCT03468127 unknown statusnot on this map

A Meta-analysis of 46 Studies Identified by the FDA on the Effect of Soy Protein on Lipid Markers (LDL-Cholesterol [LDL-C] and Total Cholesterol [TC]) as Surrogates of Cardiovascular Disease

TypeobservationalSponsorUniversity of TorontoRan2018 to 2018Enrolled1ConditionsCardiovascular DiseasesArmsSoy foods
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 9 syntheses or guidelines pooled it, 133 citations in OpenAlex.

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  9. Cumulative Meta-Analysis of the Soy Effect Over Time.Journal of the American Heart Association · 2019
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  20. Fine Mapping ofPlants (Basel, Switzerland) · 2025
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8 more citing papers are in PubMed but not listed here.

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

11 authors at 3 institutions in 2 countries.

Sonia Blanco MejiaDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Mark MessinaSoy Nutrition Institute, St. Louis, MO, USA.
Siying S LiDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Effie ViguilioukDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Laura ChiavaroliDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Tauseef A KhanDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Korbua SrichaikulDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Arash MirrahimiDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
John L SievenpiperDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Penny Kris-EthertonDepartment of Nutritional Sciences, The Pennsylvania State University, University Park, PA.
David J A JenkinsDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
St. Michael's Hospital · CAUniversity of Toronto · CAPennsylvania State University · US

Funding

CIHR 129920
6 · The paper itself

Abstract

backgroundCertain plant foods (nuts and soy protein) and food components (viscous fibers and plant sterols) have been permitted by the FDA to carry a heart health claim based on their cholesterol-lowering ability. The FDA is currently considering revoking the heart health claim for soy protein due to a perceived lack of consistent LDL cholesterol reduction in randomized controlled trials.

objectiveWe performed a meta-analysis of the 46 controlled trials on which the FDA will base its decision to revoke the heart health claim for soy protein.

methodsWe included the 46 trials on adult men and women, with baseline circulating LDL cholesterol concentrations ranging from 110 to 201 mg/dL, as identified by the FDA, that studied the effects of soy protein on LDL cholesterol and total cholesterol (TC) compared with non-soy protein. Two independent reviewers extracted relevant data. Data were pooled by the generic inverse variance method with a random effects model and expressed as mean differences with 95% CI. Heterogeneity was assessed and quantified.

resultsOf the 46 trials identified by the FDA, 43 provided data for meta-analyses. Of these, 41 provided data for LDL cholesterol, and all 43 provided data for TC. Soy protein at a median dose of 25 g/d during a median follow-up of 6 wk decreased LDL cholesterol by 4.76 mg/dL (95% CI: -6.71, -2.80 mg/dL, P < 0.0001; I2 = 55%, P < 0.0001) and decreased TC by 6.41 mg/dL (95% CI: -9.30, -3.52 mg/dL, P < 0.0001; I2 = 74%, P < 0.0001) compared with non-soy protein controls. There was no dose-response effect or evidence of publication bias for either outcome. Inspection of the individual trial estimates indicated most trials (∼75%) showed a reduction in LDL cholesterol (range: -0.77 to -58.60 mg/dL), although only a minority of these were individually statistically significant.

conclusionsSoy protein significantly reduced LDL cholesterol by approximately 3-4% in adults. Our data support the advice given to the general public internationally to increase plant protein intake. This trial was registered at clinicaltrials.gov as NCT03468127.

Indexed as

AdultCholesterolCholesterol, LDLFemaleHumansHypercholesterolemiaMaleRandomized Controlled Trials as TopicSoybean ProteinsUnited StatesUnited States Food and Drug AdministrationCholesterolCholesterol, LDLSoybean Proteinscardiovascular disease preventionLDL cholesterollipidsmeta-analysissoy proteintotal cholesterol

Identifiers

PMID31006811
PMCPMC6543199
OpenAlexW2941101778

What OpenQuestion holds

Textmetadata
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.