Meta AnalysisID 7099
评估补充藏红花对糖尿病前期和2型糖尿病患者氧化应激、炎症指标、肾和肝功能参数的影响：随机临床试验的GRADE分级系统评价与Meta分析
CRD42023458119
To study and evaluate RCTs in order to answering the following question: how much is the effect of saffron on levels of inflammatory factors and oxidative stress biomarkers and renal and liver functional tests in patient
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Record Fields
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- Meta Analysis Id
- 7099
- Evidence Id
- 15657
- Core Evidence Id
- 15657
- Source Meta Analysis Id
- 7079
- Herb2 Meta Analysis Id
- HBMA007079
- Crd Id
- CRD42023458119
- Title
- Assessing the effect of Saffron (Crocus sativus L.) supplementation on oxidative stress, inflammatory indices, renal and liver functional parameters in patients with prediabetes and type 2 diabetes mellitus: A GRADE-assessed systematic review and meta-analysis of Randomized Clinical Trials
- Review Question
- To study and evaluate RCTs in order to answering the following question: how much is the effect of saffron on levels of inflammatory factors and oxidative stress biomarkers and renal and liver functional tests in patient with prediabetes and type 2 diabetes mellitus?
- Study Type Included
- We included Studies with following criteria: 1) clinical trials with either cross-over design or parallel; 2) trials performed on diabetic population being over 18 years old; 3) trials examined the effects of saffron or crocin oral supplementation on the levels of liver enzymes (ALT, AST, and ALP) or/and renal function-related indices (BUN and Cr) and/or inflammatory parameters and/or Oxidative stress indicators as the primary or secondary findings compared to a control group; 4) RCTs that provided sufficient data on the baseline and final values of the outcomes of interest in both saffron and control groups; 5) trials on patients with T2DM as well as pre-diabetic individuals 6) relevant preprints were also included to the study. We excluded Studies if they were: 1) non-RCTs; 2) Articles without saffron intervention; 3) review articles, cross-sectional, case-control, congress abstracts (had no full-text) or cohort studies; 4) the saffron with unclear dosage.
- Condition Being Studied
- Diabetes mellitus (DM) is a group of endocrine metabolic diseases that is widespread worldwide and is a major public health concern in the world. It has been estimated that 5–10 % of individuals with prediabetes develop type 2 diabetes mellitus (T2DM) annually. DM has side effects on several organs such as heart, kidney, eye and nerve cells, and causes complications and affect the quality of life of patients. Hyperglycemia and hypertension are the most important complications of diabetes. Therefore, metabolic control is an effective preventive strategy in T2D to decrease the severe complications. Saffron has been used for many years in Iran as the most expensive traditional spice. It contains three main secondary metabolites including soluble crocin, picrocrocin, and safranal as well as crocetin. Antioxidant and anti-inflammatory properties of saffron extract have been attributed to the presence of these secondary metabolites. This systematic reviews and meta-analysis summarizes the effect of saffron supplementation on inflammatory, oxidative stress, renal and liver functional parameters in prediabetes and T2DM patients.
- Participant
- Type-2 diabetic and prediabetic patients are participants in this study.
- Animal
- Human Disease Modelled
- Intervention
- Dose of saffron daily supplementation, intervention duration, follow-up levels of means and SDs data of each parameter in oxidative stress markers, inflammatory factors, renal and liver functional parameters among both intervention and control groups in patients with prediabetes and type 2 diabetes mellitus.
- Comparator Control
- Prediabetic and type 2 diabetic patients who did not receive a supplement dose of saffron were selected as comparators.
- Main Outcome
- The means and SDs data of each parameter in oxidative stress markers, inflammatory factors, renal and liver functional parameters, including MDA, TAC, TNF-a, hs-CRP, IL-6, IL-10, AST, ALT, ALP, BUN, CR in start-point and end-point of treatment duration were measured in intervention group compared to the control group. Measures of effect Meta-analysis was performed to define the effect size using the standardized mean differences (SMDs) with 95% CIs and was calculated the endpoint values of outcome changes including different design of researches (parallel or crossover), publication year, patient characterize (age, gender, BMI ), dose and duration of intervention, inflammatory, oxidative stress, renal and liver functional parameters between the effects of saffron supplementation treatment compared to control group in prediabetes and type-2 diabetes patients.
- Outcome Measure
- Additional Outcome
- Not applicable. Measures of effect None.
- Study Method
- Intervention, Meta-analysis, Prospective meta-analysis (PMA), Synthesis of qualitative studies, Systematic review
- Keyword
- Biomarkers; Crocus; Diabetes Mellitus, Type 2; Dietary Supplements; Humans; Liver; Oxidative Stress; Prediabetic State; Randomized Controlled Trials as Topic
- Contact
- Alireza Mafi [email protected]
- Organisational Affiliation
- Isfahan University of Medical Sciences
- Funding Source
- Nutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Iran
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-08-28
- Registration Date
- 2023-09-07
- Anticipated Start Date
- 2023-07-25
- Anticipated Completion Date
- 2023-09-15
- Title Cn
- 评估补充藏红花对糖尿病前期和2型糖尿病患者氧化应激、炎症指标、肾和肝功能参数的影响：随机临床试验的GRADE分级系统评价与Meta分析
- Title En
- Assessing the effect of Saffron (Crocus sativus L.) supplementation on oxidative stress, inflammatory indices, renal and liver functional parameters in patients with prediabetes and type 2 diabetes mellitus: A GRADE-assessed systematic review and meta-analysis of Randomized Clinical Trials
- Bilingual Status
- complete