- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02037321
Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk
Effect of Substituting Vegetable Protein for Animal-Protein on Cardiometabolic Risk: A Series of Systematic Reviews and Meta-Analyses of Controlled Feeding Trials to Provide Evidence-Based Guidance for Nutrition Guidelines Development
Panoramica dello studio
Stato
Descrizione dettagliata
Background: Vegetarian diets have been associated with a reduced risk of preventable cardiometabolic diseases such as type 2 diabetes and cardiovascular disease. It is unclear whether the replacement of animal protein with vegetable protein has cardiometabolic advantages.
Objectives: To improve evidence-based guidance for dietary guidelines and health claims development, we propose to conduct a series of systematic reviews and meta-analyses of the effects of plant-based protein in replacement for animal protein on cardiometabolic risk factors including: (1) blood lipids, (2) glycemic control, (3) blood pressure, (4) body weight, (5) uric acid, (6) markers of non-alcoholic fatty liver disease (NAFLD), and (7) kidney function and injury.
Design: The planning and conduct of the proposed meta-analyses will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms.
Study selection: Long term (≥ 3 weeks), randomized, controlled trials that investigate the effect of exchange of plant proteins for animal proteins on the outcomes previously mentioned in humans will be included. Studies that have an acute feeding design, are not randomized, or lack a suitable control will not be included. Both isocaloric and non-isocaloric studies will be included.
Data extraction: Independent investigators (≥2) will extract information about study design, sample size, subject characteristics, pulse form, dose, follow-up, and the composition of the background diets. Mean±SEM values will be extracted for all outcomes. Standard computations and imputations will be used to derive missing variance data. Risk of bias and study quality will be assessed using the Cochrane Risk of Bias Tool and the Heyland Methodological Quality Score (MQS), respectively.
Outcomes: The proposed syntheses will each assess a set of outcomes related to a different area of cardiometabolic risk: (1) blood lipids (established therapeutic targets for the prevention of cardiovascular disease - LDL-C, apo-B, non-HDL-C), (2) glycemic control (glycated blood proteins, fasting glucose and insulin, and Homeostasis model assessment of insulin resistance [HOMA-IR]), (3) body weight, (4) uric acid, (5) blood pressure (systolic BP and diastolic BP), (6) markers of NAFLD (imaging and spectroscopy endpoints of liver fat and biomarkers of hepatocellular injury [transaminases]), and (7) kidney injury and function (creatinine, urea, creatine clearance, estimated glomerular filtration rate [eGFR], albumin-to-creatine ratio [ACR], albuminuria, proteinuria).
Data synthesis: Separate pooled analyses will be conducted for each area of cardiometabolic control using the Generic Inverse Variance method. Random-effects models will be used even in the absence of statistically significant between-study heterogeneity, as they yield more conservative summary effect estimates in the presence of residual heterogeneity. Exceptions will be made for the use of fixed-effects models where there is <5 included trials irrespective of heterogeneity or small trials are being pooled with larger more precise trials in the absence of statistically significant heterogeneity. Paired analyses will be applied to all crossover trials. Heterogeneity will be tested by Cochran's Q statistic and quantified by the I2 statistic. Sources of heterogeneity will be explored by sensitivity and subgroup analyses. A priori subgroup analyses will include study design, dose, vegetable protein type, animal protein comparator, follow-up, baseline values, and study quality. Significant unexplained heterogeneity will be investigated by additional post hoc subgroup analyses (e.g. age, sex, level of feeding control [metabolic, supplemented, dietary advice], washout in crossover trials, energy balance of the background diet, composition of the background diet [total % energy from fat, carbohydrate, protein], change in cholesterol intake, change in glycemic index, etc.). Meta-regression analyses will assess the significance of subgroups analyses. Publication bias will be investigated by the inspection of funnel plots and application of Egger's and Begg's tests.
Knowledge translation plan: Results will be disseminated through traditional means such as interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Innovative means such as webcasts with e-mail feedback mechanisms will also be used. Knowledge Users will act as knowledge brokers networking among opinion leaders and different adopter groups to increase awareness at each stage. Four Knowledge Users will also participate directly as members of nutrition guidelines committees. Target adopters will include the clinical practice, public health, industry, research communities, and patient groups. Feedback will be incorporated and used to guide analyses and improve key messages at each stage.
Significance: The proposed project will demonstrate that the improvement in longterm health measures. This demonstration will aid in knowledge translation related to the effects of plant proteins on cardiometabolic risk, kidney disease management, and metabolic syndrome, strengthening the evidence-base for dietary recommendations and health claims and improving health outcomes through informing healthcare providers and patients, stimulating industry innovation, and guiding future research.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5C 2T2
- Toronto 3-D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Dietary trials in humans
- Randomized treatment allocation
- >=3 weeks
- Suitable control (i.e. exchange with animal-protein)
- Viable endpoint data
Exclusion Criteria:
- Non-human studies
- Nonrandomized treatment allocation
- <3 weeks
- Lack of a suitable control (i.e. no exchange with animal-protein)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Analisi della pressione sanguigna (BP).
Lasso di tempo: Fino a 2 anni
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PA sistolica, PA diastolica, pressione arteriosa media (MAP)
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Fino a 2 anni
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Glycemic control analysis
Lasso di tempo: Up to 2-years
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Glycated blood proteins (HbA1c, total glycated hemoglobin, fructosamine, glycated albumin), fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance (HOMA-IR)
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Up to 2-years
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Lipid control analysis
Lasso di tempo: Up to 2-years
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Established therapeutic targets for cardiovascular prevention (LDL-C, apoB, non-HDL-C)
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Up to 2-years
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Kidney function and injury analysis
Lasso di tempo: Up to 2-years
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creatinine, blood urea, creatine clearance (CrCl), estimated glomerular filtration rate (eGFR), albumin-to-creatine ratio (ACR), albuminuria, proteinuria
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Up to 2-years
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Body weight analysis
Lasso di tempo: Up to 2-years
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body weight
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Up to 2-years
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Uric acid analysis
Lasso di tempo: Up to 2-years
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uric acid
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Up to 2-years
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Non-alcoholic fatty liver disease (NAFLD) analysis
Lasso di tempo: Up to 2-years
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Imaging and spectroscopy endpoints of liver fat and biomarkers of hepatocellular injury (transaminases])
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Up to 2-years
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Russell J de Souza, ScD, RD, Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Epidemiology and Biostatistics, McMaster University
- Investigatore principale: David JA Jenkins, MD, PhD, DSc, Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences and Medicine, University of Toronto
- Investigatore principale: John L Sievenpiper, MD, PhD, Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Pathology and Molecular Medicine, Faculty of health Sciences, McMaster University
- Direttore dello studio: Cyril WC Kendall, PhD, Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital and Department of Nutritional Sciences and Medicine, University of Toronto
Pubblicazioni e link utili
Pubblicazioni generali
- Li SS, Blanco Mejia S, Lytvyn L, Stewart SE, Viguiliouk E, Ha V, de Souza RJ, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Effect of Plant Protein on Blood Lipids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2017 Dec 20;6(12):e006659. doi: 10.1161/JAHA.117.006659.
- Viguiliouk E, Stewart SE, Jayalath VH, Ng AP, Mirrahimi A, de Souza RJ, Hanley AJ, Bazinet RP, Blanco Mejia S, Leiter LA, Josse RG, Kendall CW, Jenkins DJ, Sievenpiper JL. Effect of Replacing Animal Protein with Plant Protein on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2015 Dec 1;7(12):9804-24. doi: 10.3390/nu7125509.
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Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie urologiche
- Peso corporeo
- Resistenza all'insulina
- Iperinsulinismo
- Disturbi del metabolismo lipidico
- Malattie del fegato
- Malattia cardiovascolare
- Malattie renali
- Fegato grasso
- Sindrome metabolica
- Dislipidemie
- Sovrappeso
- Malattia del fegato grasso non alcolica
Altri numeri di identificazione dello studio
- MetaVeg2013
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