Urinary Metabolic Phenotyping of Diet-cardiovascular Disease Risk Associations: the OmniHeart Feeding Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 主要终点
- Systolic blood pressure (SBP)
研究概览
简要总结
To compare the urinary metabolomes on individuals undergone three different healthy diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.
详细描述
BACKGROUND:
This study based on the OmniHeart dietary intervention study, a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of three DASH-like diets: a carbohydrate-rich (CARB) diet pattern, a rich in protein (PROT) and a rich in unsaturated (MUFA) fat, predominantly monounsaturated fat diet (see full details of OmniHeart dietary intervention https://clinicaltrials.gov/ct2/show/record/NCT00051350).
This metabonomic study aims to evaluate the feasibility of identifying individuals showing variation in clinical response to three different healthy diets, with the purpose of reducing cardiovascular disease (CVD) risk, using proton nuclear magnetic resonance (NMR) based metabolic phenotyping approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •with pre-hypertension (systolic BP of 120 to 139 mmHg and/or diastolic BP of 80 to 89 mmHg) or stage 1 hypertension (systolic BP of 140 to 159 mm Hg and/or diastolic BP of 90 to 99 mm Hg) and without diabetes or prior CVD
排除标准
- •CVD or diabetes
研究组 & 干预措施
Baseline
Baseline corresponds to typical American diet
干预措施: CARB rich diet (Other)
Baseline
Baseline corresponds to typical American diet
干预措施: MUFA rich diet (Other)
Baseline
Baseline corresponds to typical American diet
干预措施: PROT rich diet (Other)
PROT rich diet
Protein rich diet for 6 weeks
干预措施: CARB rich diet (Other)
PROT rich diet
Protein rich diet for 6 weeks
干预措施: MUFA rich diet (Other)
MUFA rich diet
MUFA rich diet for 6 weeks
干预措施: CARB rich diet (Other)
MUFA rich diet
MUFA rich diet for 6 weeks
干预措施: PROT rich diet (Other)
CARB rich diet
CARB rich diet for 6 weeks
干预措施: MUFA rich diet (Other)
CARB rich diet
CARB rich diet for 6 weeks
干预措施: PROT rich diet (Other)
结局指标
主要结局
Systolic blood pressure (SBP)
时间窗: post 6 weeks intervention
SBP reduction in mmHg
次要结局
- high density lipoprotein cholesterol (HDL)(post 6 weeks intervention)
- triglycerides (TG)(post 6 weeks intervention)
- total cholesterol(post 6 weeks intervention)
- Diastolic blood pressure (DBP)(post 6 weeks intervention)
- low density lipoprotein cholesterol (LDL)(post 6 weeks intervention)