Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
BMJ Open. 2022 Jul 6;12(7):e058875. doi: 10.1136/bmjopen-2021-058875.
This review aims to assess the effects of dietary supplementation with inulin-type fructans (ITF) compared with no supplementation on cardiovascular disease risk factors in adults and assess the quality of trial reporting using the Consolidated Standards of Reporting Trials (CONSORT) and CONSORT for abstract (CONSORT-A) checklists.
We will search randomised controlled trials (RCTs) in MEDLINE, EMBASE, CINAHL, Emcare, AMED and the Cochrane Database of Systematic Reviews from inception to 31 March 2022, without any language restrictions. The RCTs need to administer ITF in adults for at least 2 weeks and assess effects on at least one cardiovascular risk factor. We will exclude RCTs that (1) assessed the postprandial effects of ITF; (2) included pregnant or lactating participants; (3) enrolled participants undergoing treatment that might affect the response to ITF. We will assess the study risk of bias (RoB) using V.2 of the Cochrane RoB tool for RCTs (RoB 2) and the certainty of the evidence using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. We will pool data using a random-effects model. We will use the χ test to compare compliance of CONSORT and CONSORT-A checklists and Poisson regression to identify factors associated with better reporting.
Ethics approval is not required for secondary analysis of already published data. We will publish the reviews in a peer-review journal.
CRD42019136745.
本综述旨在评估与不补充相比，菊粉型果聚糖（ITF）的饮食补充对成年人心血管疾病风险因素的影响，并使用 CONSORT 及 CONSORT 摘要（CONSORT-A）清单评估试验报告的质量。
我们将从建库至 2022 年 3 月 31 日，在 MEDLINE、EMBASE、CINAHL、Emcare、AMED 和 Cochrane 系统评价数据库中，对随机对照试验（RCT）进行检索，不设任何语言限制。RCT 需在成年人中至少补充 ITF 2 周，并评估对至少一种心血管风险因素的影响。我们将排除以下 RCT：（1）评估 ITF 餐后效应的 RCT；（2）包含孕妇或哺乳期参与者的 RCT；（3）纳入可能影响 ITF 反应的正在接受治疗的参与者的 RCT。我们将使用 Cochrane RCT 偏倚风险工具（RoB 2）评估研究偏倚（RoB），使用推荐评估、制定与评价分级（GRADE）方法评估证据的确定性。我们将使用随机效应模型对数据进行合并。我们将使用 χ 检验比较 CONSORT 和 CONSORT-A 清单的符合率，并使用泊松回归确定与更好报告相关的因素。
对已发表数据进行二次分析不需要伦理批准。我们将在同行评审期刊上发表综述。
PROSPERO 注册号：CRD42019136745。
