NCT02070770已完成不适用
The Effect of Short-term Adherence to a Very Low Calorie Diet on Heart Rate Variability: a Pilot Randomised Controlled Trial in Obese Men and Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change from baseline in 24 h SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
研究概览
简要总结
The purpose of this study is to determine whether short-term adherence to a very low calorie diet is effective in improving heart rate variability in obese individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking men and women
- •Aged 32-65 years
- •BMI 30-42 kg/m2
排除标准
- •History of cardiovascular disease, diabetes, cancer, renal or liver disease or chronic gastrointestinal disorder
- •Epileptic or history of fainting
- •Adhered to a VLCD in the past 6 months
- •History of drug or alcohol abuse including heavy drinking.
- •Pregnancy, planning to get pregnant or breastfeeding
- •Currently taking medications to control blood pressure
- •Weight change of over 3kg in the past two months
结局指标
主要结局
Change from baseline in 24 h SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7
时间窗: Baseline, day 7
SDNN is a time domain parameter of overall heart rate variability
次要结局
- Change from baseline in night-time pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7(Baseline, day 7)
- Change from baseline in 24 h mean IBI (interbeat interval) at day 7(Baseline, day 7)
- Change from baseline in 24 h SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7(Baseline, day 7)
- Change from baseline in 24 h triangular index at day 7(Baseline, day 7)
- Change from baseline in night-time RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7(Baseline, day 7)
- Change from baseline in daytime SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7(Baseline, day 7)
- Change from baseline in night-time mean IBI (interbeat interval) at day 7(Baseline, day 7)
- Change from baseline in daytime mean IBI (interbeat interval) at day 7(Baseline, day 7)
- Change from baseline in 24 h pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7(Baseline, day 7)
- Change from baseline in night-time SDNN (mean of the standard deviations of the normal-to-normal intervals) at day 7(Baseline, day 7)
- Change from baseline in daytime SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7(Baseline, day 7)
- Change from baseline in night-time triangular index at day 7(Baseline, day 7)
- Change from baseline in daytime triangular index at day 7(Baseline, day 7)
- Change from baseline in night-time LF (low frequency power) at day 7(Baseline, day 7)
- Change from baseline in night-time SDANN (standard deviations of the average normal-to-normal intervals calculated over periods of 5-minutes) at day 7(Baseline, day 7)
- Change from baseline in daytime RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7(Baseline, day 7)
- Change from baseline in night-time HF (high frequency power) at day 7(Baseline, day 7)
- Change from baseline in daytime LF/HF at day 7(Baseline, day 7)
- Change from baseline in 24 h RMSSD (root mean square of successive differences of normal-to-normal differences) at day 7(Baseline, day 7)
- Change from baseline in daytime LF (low frequency power) at day 7(Baseline, day 7)
- Change from baseline in 24 h HF (high frequency power) at day 7(Baseline, day 7)
- Change from baseline in daytime HF (high frequency power) at day 7(Baseline, day 7)
- Change from baseline in daytime pNN50 (% differences between adjacent normal-to-normal intervals that are >50 ms) at day 7(Baseline, day 7)
- Change from baseline in 24 h LF (low frequency power) at day 7(Baseline, day 7)
- Change from baseline in 24 h LF/HF at day 7(Baseline, day 7)
- Change from baseline in night-time LF/HF at day 7(Baseline, day 7)
- Change from baseline in 24 h VLF (very low frequency power) at day 7(Baseline, day 7)
- Change from baseline in night-time VLF (very low frequency power) at day 7(Baseline, day 7)
- Change from baseline in daytime VLF (very low frequency power) at day 7(Baseline, day 7)
研究者
Dr Wendy Hall
Lecturer in Nutritional Sciences
King's College London
研究点 (2)
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