Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis

Introduction According to the common definition, nutraceuticals are components found in food that can act as therapeutic substances. Recently, the International Lipid Expert Panel published two position papers covering the topic of lipid-lowering nutraceuticals and their potential use as a complemen...

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Main Authors: Maciej Banach, Lukas Schwingshackl, Mariusz Gasior, Jakub Morze, Tadeusz Osadnik, Kamila Osadnik, Mateusz Lejawa, Grzegorz Jakubiak, Natalia Pawlas
Format: Article
Language:English
Published: BMJ Publishing Group 2020-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/8/e032755.full
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author Maciej Banach
Lukas Schwingshackl
Mariusz Gasior
Jakub Morze
Tadeusz Osadnik
Kamila Osadnik
Mateusz Lejawa
Grzegorz Jakubiak
Natalia Pawlas
author_facet Maciej Banach
Lukas Schwingshackl
Mariusz Gasior
Jakub Morze
Tadeusz Osadnik
Kamila Osadnik
Mateusz Lejawa
Grzegorz Jakubiak
Natalia Pawlas
author_sort Maciej Banach
collection DOAJ
description Introduction According to the common definition, nutraceuticals are components found in food that can act as therapeutic substances. Recently, the International Lipid Expert Panel published two position papers covering the topic of lipid-lowering nutraceuticals and their potential use as a complementary treatment in addition to statins or as an alternative treatment in statin-intolerant patients. The aim of this study was to compare the effect of different nutraceuticals on lipid profiles in a systematic review with pairwise and network meta-analyses.Methods and analysis Three databases, including PubMed, Embase and the Cochrane Central Register of Controlled Trials, will be searched without time or publication language restrictions. The estimated end date for the searches will be 29 March 2020. Each stage of the review, including the study section, data extraction, and risk of bias and quality of evidence assessments, will be performed in duplicate. Randomised controlled trials meeting the following criteria will be eligible for inclusion: (1) participants aged ≥18 years, (2) intervention with a selected nutraceutical (artichoke, berberine, bergamot, soluble fibres, green tea, garlic, lupin, plant sterols and stanols, red yeast rice, soybean, spirulina or a combination of the aforementioned nutraceuticals), (3) administration of the treatment in the form of capsules, pills, powders, solutions, tablets or enriched food items, (4) comparison with another nutraceutical or placebo, (5) intervention period ≥3 weeks and (6) lipid profile (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglycerides) as an outcome. Random-effect pairwise and network meta-analyses will be used to summarise the relative effect of each nutraceutical in comparison to the effect of every other nutraceutical. Subgroup analyses will be stratified by age, sex, ethnicity, sample size, length of trial follow-up, baseline cholesterol level and presence of other comorbidities.Ethics and dissemination This review will summarise findings from primary studies, and therefore no ethics approval is required. The results will be presented at conferences as well as published in a peer-reviewed journal.PROSPERO registration number CRD42019132877.
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spelling doaj-art-4d1c710aff0a4b28b94cdb4efc2b0adf2025-08-20T02:50:55ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2019-032755Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysisMaciej Banach0Lukas Schwingshackl1Mariusz Gasior2Jakub Morze3Tadeusz Osadnik4Kamila Osadnik5Mateusz Lejawa6Grzegorz Jakubiak7Natalia Pawlas8Polish Mother`s Memorial Hospital Research Institute (PMMHRI), Lodz, PolandInstitute for Evidence in Medicine, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany3rd Department of Cardiology, School of Medicine with the Division of Dentistry, Medical University of Silesia, Zabrze, PolandDepartment of Cardiology and Internal Diseases, University of Warmia and Mazury, Olsztyn, PolandDepartment of Pharmacology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Zabrze, PolandDepartment of Pharmacology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Zabrze, PolandDepartment of Pharmacology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Zabrze, PolandDepartment of Pharmacology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Zabrze, PolandDepartment of Pharmacology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Zabrze, PolandIntroduction According to the common definition, nutraceuticals are components found in food that can act as therapeutic substances. Recently, the International Lipid Expert Panel published two position papers covering the topic of lipid-lowering nutraceuticals and their potential use as a complementary treatment in addition to statins or as an alternative treatment in statin-intolerant patients. The aim of this study was to compare the effect of different nutraceuticals on lipid profiles in a systematic review with pairwise and network meta-analyses.Methods and analysis Three databases, including PubMed, Embase and the Cochrane Central Register of Controlled Trials, will be searched without time or publication language restrictions. The estimated end date for the searches will be 29 March 2020. Each stage of the review, including the study section, data extraction, and risk of bias and quality of evidence assessments, will be performed in duplicate. Randomised controlled trials meeting the following criteria will be eligible for inclusion: (1) participants aged ≥18 years, (2) intervention with a selected nutraceutical (artichoke, berberine, bergamot, soluble fibres, green tea, garlic, lupin, plant sterols and stanols, red yeast rice, soybean, spirulina or a combination of the aforementioned nutraceuticals), (3) administration of the treatment in the form of capsules, pills, powders, solutions, tablets or enriched food items, (4) comparison with another nutraceutical or placebo, (5) intervention period ≥3 weeks and (6) lipid profile (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglycerides) as an outcome. Random-effect pairwise and network meta-analyses will be used to summarise the relative effect of each nutraceutical in comparison to the effect of every other nutraceutical. Subgroup analyses will be stratified by age, sex, ethnicity, sample size, length of trial follow-up, baseline cholesterol level and presence of other comorbidities.Ethics and dissemination This review will summarise findings from primary studies, and therefore no ethics approval is required. The results will be presented at conferences as well as published in a peer-reviewed journal.PROSPERO registration number CRD42019132877.https://bmjopen.bmj.com/content/10/8/e032755.full
spellingShingle Maciej Banach
Lukas Schwingshackl
Mariusz Gasior
Jakub Morze
Tadeusz Osadnik
Kamila Osadnik
Mateusz Lejawa
Grzegorz Jakubiak
Natalia Pawlas
Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis
BMJ Open
title Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis
title_full Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis
title_fullStr Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis
title_full_unstemmed Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis
title_short Comparative effect of nutraceuticals on lipid profile: a protocol for systematic review and network meta-analysis
title_sort comparative effect of nutraceuticals on lipid profile a protocol for systematic review and network meta analysis
url https://bmjopen.bmj.com/content/10/8/e032755.full
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