Dietary Approaches for Improving Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Triglyceride : HDL cholesterol ratio
研究概览
简要总结
This pilot study aims to recruit 30 adults with abdominal obesity, without major chronic disease, and test whether clinical dietary advice that is solely focused on the timing of eating (time restricted eating), has an effect on cardiometabolic health compared to standard dietary advice for cardiometabolic health, which is focused on content. The goal of this pilot study is to develop and hone dietary counseling approaches for time restricted eating for RD's in a clinical practice paradigm, and collect data on testing this intervention compared to standard dietary counseling approaches for cardiometabolic health.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants are blinded to the nature of the other intervention so as not to contaminate the intervention. The clinical research staff taking the measurements is also blinded to the respective intervention the participant has been randomized to.
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Abdominal obesity (waist circumference ≥35" for women and ≥40" for men; if Asian ethnicity, ≥35" for men and ≥31.5" for women)
- •weight stable over the previous 2 months
- •medications stable for > 3 months
- •self-reported 24-hr sleep-wake patterns within the appropriate range as defined by the National Sleep Foundation (self-reported habitual sleep duration 6-10 hours during nocturnal hours)
- •regular meal patterns
- •from the greater UCI and Orange county area
- •willing to incorporate a dietary approach aimed at improving cardiometabolic health and weight management
- •able to speak, read and understand English or Spanish
排除标准
- •Self-reported unstable hypertension
- •Type 1 or 2 diabetes mellitus
- •heart, renal, or liver disease
- •cancer or active neoplasms
- •hyperthyroidism unless treated and under control
- •taking any medications known to affect clinical risk measures of interest or weight/energy expenditure (except for stable blood pressure medication)
- •active usual smoking (tobacco or marijuana)
- •alcohol intake > 3 drinks/day
- •pregnancy, current lactation, or plans to become pregnant during the study
结局指标
主要结局
Triglyceride : HDL cholesterol ratio
时间窗: 8 weeks
Ratio of fasting triglycerides to HDL cholesterol
次要结局
- Weight(8 weeks)
- HOMA-IR(8 weeks)
- Objective sleep and physical activity habits(Run-in (up to 2 weeks), Intervention (8 weeks))
- Glucose(8 weeks)
- Insulin(8 weeks)
- Waist Circumference(8 weeks)
- LDL cholesterol(8 weeks)
- Blood pressure(8 weeks)
- Diet Quality(Run-in (up to 2 weeks), Intervention (8 weeks))
- Post-hoc estimated energy intake(8 weeks)
研究者
Andrew Odegaard
Assistant Professor
University of California, Irvine