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

Adult Cholesterol / blood Cholesterol, LDL / blood Female Humans Hypercholesterolemia / blood Male Randomized Controlled Trials as Topic / statistics & numerical data Soybean Proteins / administration & dosage United States United States Food and Drug Administration
LDL cholesterol cardiovascular disease prevention lipids meta-analysis soy protein total cholesterol

Journal

The Journal of nutrition
ISSN: 1541-6100
Titre abrégé: J Nutr
Pays: United States
ID NLM: 0404243

Informations de publication

Date de publication:
01 06 2019
Historique:
received: 10 09 2018
revised: 05 11 2018
accepted: 25 01 2019
pubmed: 23 4 2019
medline: 9 4 2020
entrez: 23 4 2019
Statut: ppublish

Résumé

Certain 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. We 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. We 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. Of 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. Soy 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.

Sections du résumé

BACKGROUND
Certain 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.
OBJECTIVE
We 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.
METHODS
We 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.
RESULTS
Of 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.
CONCLUSIONS
Soy 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.

Identifiants

DOI: 10.1093/jn/nxz020 PMID: 31006811 PMC: PMC6543199
pubmed: 31006811
pii: S0022-3166(22)16634-4
doi: 10.1093/jn/nxz020
pmc: PMC6543199
doi:

Substances chimiques

Cholesterol, LDL 0
Soybean Proteins 0
Cholesterol 97C5T2UQ7J

Banques de données

ClinicalTrials.gov
['NCT03468127']

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

968-981

Subventions

Organisme : CIHR
ID : 129920
Pays : Canada

Informations de copyright

Copyright © American Society for Nutrition 2019.

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Auteurs

Sonia Blanco Mejia (S)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital,Toronto, ON, Canada.

Mark Messina (M)

Soy Nutrition Institute, St. Louis, MO, USA.

Siying S Li (SS)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
School of Medicine, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.

Effie Viguiliouk (E)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital,Toronto, ON, Canada.

Laura Chiavaroli (L)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital,Toronto, ON, Canada.

Tauseef A Khan (TA)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital,Toronto, ON, Canada.

Korbua Srichaikul (K)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

Arash Mirrahimi (A)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

John L Sievenpiper (JL)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital,Toronto, ON, Canada.
Division of Endocrinology and Metabolism, Department of Medicine, St. Michael's Hospital, Toronto, ON, Canada.
Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.
Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

Penny Kris-Etherton (P)

Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA.

David J A Jenkins (DJA)

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital,Toronto, ON, Canada.
Division of Endocrinology and Metabolism, Department of Medicine, St. Michael's Hospital, Toronto, ON, Canada.
Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.
Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

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