Meta AnalysisID 7006
可可摄入对心血管代谢风险参数的影响:随机对照试验的系统评价与Meta分析方案
CRD42023484490
* To analyze if cocoa or dark chocolate can improve and prevent cardiometabolic risk parameters such as blood pressure, glucose, cholesterol, triglycerides, body mass, HDL, LDL, and HbA1c through the analysis of randomiz
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 7006
- Evidence Id
- 15564
- Core Evidence Id
- 15564
- Source Meta Analysis Id
- 6992
- Herb2 Meta Analysis Id
- HBMA006992
- Crd Id
- CRD42023484490
- Title
- Effect of Cocoa Consumption on Cardiometabolic Risk Parameters: protocol for a systematic review and meta-analysis of randomized controlled trials
- Review Question
- * To analyze if cocoa or dark chocolate can improve and prevent cardiometabolic risk parameters such as blood pressure, glucose, cholesterol, triglycerides, body mass, HDL, LDL, and HbA1c through the analysis of randomized controlled trials. * To analyze how many milligrams of polyphenols and flavonoids (bioactive compounds) are necessary for better cardiovascular health. Specific PI(E)COS elements: * Population (P): The review will include studies involving various populations, including individuals with diabetes, metabolic syndrome, normocholesterolemia, hypercholesterolemia, hypertension, as well as healthy, middle-aged, and elderly populations. * Intervention/Exposure (I/E): The interventions of interest are the consumption of cocoa and dark chocolate, particularly focusing on the intake of polyphenols and flavonoids. Studies should have a minimum intervention period of 4 weeks. * Comparison (C): Comparisons will be made with control groups either not receiving cocoa or dark chocolate intervention or receiving a placebo. * Outcomes (O): Primary outcomes include changes in cardiometabolic risk factors such as blood pressure, glucose levels, cholesterol, triglycerides, body mass, HDL, LDL, and HbA1c. Additionally, the review will assess the necessary dosage of polyphenols and flavonoids for improved cardiovascular health. * Study Types (S): The review will focus on randomized controlled trials that provide high-quality evidence regarding the effects of cocoa and dark chocolate consumption on cardiometabolic risk factors and the required amount of polyphenols and flavonoids for cardiovascular health benefits." .
- Study Type Included
- Randomized Controlled Trials (RCTs): We will include only RCTs as they provide the highest level of evidence for assessing the efficacy of interventions. Cross-Sectional Studies: Due to their limitations in establishing causality, cross-sectional studies will not be included.
- Condition Being Studied
- Cardiovascular Risk parameters: Type 2 diabetes. Hypercholesterolemia, High Tryglicerides, Hypertension, Elderly
- Participant
- "Inclusion Criteria: Our review will include studies involving participants with: * Type 2 Diabetes: To understand the impact of cocoa and dark chocolate on glycemic control and diabetes-related metabolic parameters. * Metabolic Syndrome: Given the relationship between metabolic syndrome and increased cardiovascular risk. * Hypercholesterolemia: To assess the effects on cholesterol levels, particularly LDL and HDL. * High Triglycerides: To evaluate the influence on lipid metabolism. * Hypertension: Considering its significant role in cardiovascular health. * Healthy -as prevention for cardiovascular risk * Elderly Middle-Aged, and Young Populations: To provide a comprehensive analysis across a broad age range, understanding age-specific effects. Exclusion Criteria: The review will exclude studies focusing on populations with: * Cancer: Due to the specific metabolic and treatment-related variables that could confound the effects of cocoa and chocolate. * Pregnant Women: Considering the unique metabolic and physiological changes during pregnancy that might affect the outcomes. * Heart Failure: As the dietary needs and metabolic responses of these patients might differ significantly. * Menopause: Due to hormonal changes that could influence cardiovascular risk factors differently. * Stroke: As stroke survivors may have specific dietary and health considerations not generalizable to the broader population."
- Animal
- Human Disease Modelled
- Intervention
- Inclusion: * Supplementation/Use of Cocoa: This includes studies where participants receive cocoa in various forms such as capsules, beverages, or controlled meals. * Dark Chocolate Consumption: Studies involving the consumption of dark chocolate with a cocoa content of over 70% will be included. * Duration: The intervention period in the studies must be at least 4 weeks to ensure sufficient time for potential effects to manifest. * Polyphenol Concentration: We will include studies with any concentration of polyphenols, aiming to analyze a range of doses and their impacts on cardiovascular risk factors. Exclusion: * Short-Term Interventions: Studies with interventions lasting less than 4 weeks will be excluded, as they may not provide adequate time to observe significant changes in cardiovascular risk factors. * Lower Cocoa Content: Studies involving chocolate or cocoa products with less than 70% cocoa content will be excluded, as the focus is on high-cocoa-content products.
- Comparator Control
- * White Chocolate or Milk Chocolate: Studies using white chocolate or milk chocolate (with less than 70% cocoa content) as a comparator will be included to contrast with high-cocoa-content products. * Placebo Capsules or Drinks: Studies that utilize placebo capsules or drinks as a comparator, ensuring that the placebo is similar in appearance and taste to the cocoa product but without the active polyphenols. * No Intervention: Studies that include a control group with no intervention or dietary modification will also be included to provide a baseline for comparison. Exclusion: * Non-Comparable Interventions: Studies where the control group receives an intervention that is significantly different from the above-mentioned comparators, such as other dietary supplements or treatments not related to cocoa or chocolate, will be excluded. * Active Comparators Not Mimicking Cocoa/Chocolate: Studies using active comparators that do not mimic the physical properties of cocoa or chocolate (in case of placebo) will be excluded to ensure the integrity of the comparison. * Insufficiently Described Controls: Studies that do not adequately describe the comparator or control conditions, making it difficult to assess the validity of the comparison."
- Main Outcome
- * Blood Pressure: Measurement of systolic and diastolic blood pressure in mmHg, before and after the intervention period, using standardized blood pressure measurement techniques. * Body Mass Index (BMI): Calculation of BMI (kg/m²) using height and weight measurements taken at baseline and post-intervention. * Body Weight: Measurement of body weight in kilograms at the start and end of the intervention period. * Cholesterol Total, HDL, LDL and Triglycerides: Quantification of total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride levels in mg/dL, obtained through blood tests conducted before and after the intervention. * Waist and Abdominal Circumference: Measurement of waist circumference in centimeters as an indicator of central obesity, recorded at baseline and post-intervention. * Glucose and HbA1c: Measurement of fasting blood glucose levels (mg/dL) and glycated hemoglobin (HbA1c) percentages, assessed at baseline and at the conclusion of the intervention. * Concentrations of bioactive compounds (Total Polyphenols and Flavonoids as flavanols) : Analysis of this content in the cocoa or dark chocolate products used in the intervention, expressed in mg per serving or per specific quantity.
- Outcome Measure
- Additional Outcome
- Not applicable
- Study Method
- Meta-analysis, Prevention, Systematic review
- Keyword
- MeSH headings have not been applied to this record
- Contact
- Alexandre Lehnen [email protected]
- Organisational Affiliation
- Fundação Universitária de Cardiologia - Instituto de Cardiologia do Rio Grande do Sul https://diretoriacientificaicfuc.org.br/
- Funding Source
- This systematic review and meta-analysis is supported by a grant from CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior), Brazil. As a CAPES scholarship recipient, the funding primarily supports researchers .
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Brazil
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-11-18
- Registration Date
- 2023-11-30
- Anticipated Start Date
- 2023-11-19
- Anticipated Completion Date
- 2024-02-10
- Title Cn
- 可可摄入对心血管代谢风险参数的影响:随机对照试验的系统评价与Meta分析方案
- Title En
- Effect of Cocoa Consumption on Cardiometabolic Risk Parameters: protocol for a systematic review and meta-analysis of randomized controlled trials
- Bilingual Status
- complete