Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- weight reduction
研究概览
简要总结
A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk factors of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects.
详细描述
Background: The optimal diet for treating obesity and cardiovascular disease (CVD) risk is still not clarified. Could a five plus two diet, a form of intermittent energy restriction lead to good adherence, similar weight loss and reduction in CVD risk factors as a isocaloric continuous energy restrictions in obese subjects.
Methods: The study is a randomized controlled clinical trial in 120 men and women between 21 to 70 years with BMI (BMI 30-45 kg/m2), stable weight within ±3 kg last 3 months and 1 additional metabolic syndrome risk component.
Dietary intervention: Randomization will be to one of two diet groups. Participants in the intervention group will follow av 5:2 diet and participants in the control group will follow an isocaloric continuous energy restriction.
Primary research question: Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects? Secondary research questions Compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects. The project consist of to randomized controlled clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 21 to 70 years.
- •BMI (BMI 30-45 kg/m2).
- •stable weight within ±3 kg last 3 months.
- •1 additional metabolic syndrome risk component.
排除标准
- •Diabetes if treated with insulin or incretin analogues.
- •History of bariatric surgery.
- •Use of antiobesity drugs or supplements.
- •Eating disorder.
- •Psychiatric illness that contributes to difficulties with study procedures.
- •Alcohol or drug abuse.
研究组 & 干预措施
intermittent energy restriction
dietary intervention, intermittent energy restriction. Participants in the experimental group will follow av 5:2 diet and consume a very low calorie diet providing 400 (females) to 600 (males) calories of energy to days a week and for an average male participant, this will reduce energy intake approximately 22%.
干预措施: dietary intervention intermittent energy restriction (Other)
continuous energy restriction
dietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23%
干预措施: continuous energy restriction (Other)
结局指标
主要结局
weight reduction
时间窗: 1 year
Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects
次要结局
- HbA1c(1 year)
- adverse events(1 year)
- fasting glucose(1 year)
- triglycerides(1 year)
- C-reactive protein (CRP)(1 year)
- blood pressure(1 year)
- cholesterol(1 year)
研究者
Tine Mejlbo Sundfør
MS in Nutrition, ph-D-student
Oslo University Hospital