Effect of Intermittent Fasting Strategies on Cardiometabolic Risk: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
Intermittent fasting is a method of restricting calories over a defined period of time and includes regimens such as whole-day fasting, alternate-day fasting, and time-restricted feeding. There is emerging evidence that intermittent fasting or energy restriction might be more beneficial than continuous energy restriction for some risk factors. The effect of intermittent fasting on risk factors associated with obesity, diabetes, and cardiovascular disease, however, is not clear. The European Association for the Study of Diabetes (EASD) has yet to make any recommendations regarding the role of intermittent fasting in the management of diabetes. To inform the update of the EASD Clinical Practice Guidelines for Nutrition Therapy, tthe Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned a systematic review and network meta-analysis of randomized controlled trials of the effect of different intermittent fasting strategies on established cardiometabolic risk factors. The findings generated by this proposed knowledge synthesis will shape guide current guidelines and improve health outcomes by educating healthcare providers and patients, and by guiding future research design.
详细描述
Background: 'Intermittent fasting' is currently the most popular trending diet, yet its clinical utility remains unclear. Previous systematic reviews and meta-analyses of intermittent fasting have been limited by a narrow focus on weight loss, one specific method of intermittent fasting, and/or a subset of participants who would be the least likely to benefit. Other issues have included unexplained heterogeneity, incorrect analyses and/or lack of assessment of the certainty of the evidence. There is emerging evidence that intermittent fasting may improve cardiometabolic risk markers independent of calories. However, there is a lack of certainty about the effectiveness of intermittent fasting on overall cardiometabolic risk across different health conditions, and the differences between the various methods of intermittent fasting. The European Association for the Study of Diabetes (EASD) has yet to make any recommendations regarding the role of intermittent fasting in the management of diabetes. To inform the update of the EASD Clinical Practice Guidelines for Nutrition Therapy, the Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned a systematic review and network meta-analysis (an approach which has the advantage over traditional pairwise meta-analyses of being able to assess simultaneously multiple interventions) to assess the effect of the different strategies of intermittent energy restriction (intermittent fasting) versus continuous energy restriction and ad libitum diets on cardiometabolic risk in randomized controlled trials and assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Objective: To assess simultaneously the effect of the various strategies of intermittent energy restriction (intermittent fasting), continuous energy restriction, and ad libitum diets on body weight and other cardiometabolic risk factors in a systematic review and network meta-analysis of randomized trials using the GRADE approach.
Design: Each systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for network meta-analyses (PRISMA-Network).
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms. These searches will be supplemented by hand searches of references of included studies. Abstracts will be included and no language restrictions will be used.
Study selection: The investigators will include randomized controlled trials (RCTs) that are >=3-weeks duration investigating the effect of intermittent fasting, continuous caloric restriction and/or ad libitum diets on cardiometabolic risk factors in adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Randomized controlled trials in humans
- •Intermittent fasting intervention
- •Continuous energy restriction, ad libitum diet, or other intermittent fasting diet as comparators
- •Diet duration ≥1 weeks
- •Data for at least one prespecified outcome
- •Viable outcome data
排除标准
- •Non-human studies
- •Observational studies
- •Multi-modal interventions
- •Diet duration < 1 weeks
- •No viable outcome data
- •Lack of suitable comparator
结局指标
主要结局
Body weight
时间窗: Through study completion, up to 20 years
Body weight in kg
次要结局
- Glycemic control - HbA1c(Through study completion, up to 20 years)
- Adiposity - BMI(Through study completion, up to 20 years)
- Adiposity - Waist circumference(Through study completion, up to 20 years)
- Adiposity - Body fat(Through study completion, up to 20 years)
- Glycemic control - fasting plasma glucose (FPG)(Through study completion, up to 20 years)
- Glycemic control - 2h plasma glucose (2h-PG)(Through study completion, up to 20 years)
- Glycemic control - fasting plasma insulin (FPI)(Through study completion, up to 20 years)
- Established blood lipid targets - triglycerides(Through study completion, up to 20 years)
- Markers of non-alcoholic fatty liver disease (NAFLD) - Intrahepatocellular lipids (IHCL)(Through study completion, up to 20 years)
- Established blood lipid targets - LDL-cholesterol (LDL-C)(Through study completion, up to 20 years)
- Markers of inflammation - CRP(Through study completion, up to 20 years)
- Established blood lipid targets - HDL-cholesterol (HDL-C)(Through study completion, up to 20 years)
- Glycemic control - homeostasis model assessment of insulin resistance (HOMA-IR)(Through study completion, up to 20 years)
- Established blood lipid targets - non-HDL-cholesterol (non-HDL-C)(Through study completion, up to 20 years)
- Blood pressure - diastolic blood pressure (DBP)(Through study completion, up to 20 years)
- Established blood lipid targets - apolipoprotein B (apo B)(Through study completion, up to 20 years)
- Blood pressure - Systolic blood pressure (SBP)(Through study completion)
- Markers of non-alcoholic fatty liver disease (NAFLD) - alanine transaminase (ALT)(Through study completion, up to 20 years)
- Uric acid(Through study completion, up to 20 years)
研究者
John Sievenpiper
Professor
University of Toronto