Sodium Regulation in Individuals on Known Dietary Sodium Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Estimated sodium concentration in bone
研究概览
简要总结
The overall objective of this study is to examine how dietary sodium is used by the body. In a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. This has implications for how investigators interpret studies that use urine biomarkers of sodium. Study findings about tissue sodium storage also have implications for managing hypertension and related conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Throughout data collection, study data collectors and the study coordinator will remain blinded to participants' exposure group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old;
- •Diagnosed with high blood pressure or pre-hypertension (systolic blood pressure (SBP) > 120 mm Hg or diastolic blood pressure (DBP) > 80 mm Hg);
- •Taking no more than two medications for high blood pressure;
- •Currently has a primary care provider;
- •Willing to eat all meals provided by the study for two 14-day feeding periods;
- •Willing to complete study measurement procedures.
排除标准
- •Diabetes;
- •Serious food allergies;
- •Currently pregnant or planning to become pregnant
结局指标
主要结局
Estimated sodium concentration in bone
时间窗: 60 days
The concentration of sodium in bone will be measured, and the difference in concentrations resulting from high versus low sodium intakes will be calculated. Sodium storage in bone will be measured non-invasively using in vivo neutron activation analysis (IVNAA) technology to quantify the concentration of Na in the hand.
Concentration of sodium, potassium, and hormone regulators in excreted urine
时间窗: 60 days
Urinary concentration of sodium, potassium, and hormones (renin, angiotensin, aldosterone, free cortisol, free cortisone, glucocorticoid, and mineralocorticoid) will be measured and variation over time will be calculated.
Blood pressure
时间窗: 60 days
Blood pressure under high versus low dietary sodium conditions will be measured.
Estimated sodium concentration in skin and muscle
时间窗: 60 days
The concentration of sodium in skin and muscle will be measured, and the difference in concentrations resulting from high versus low sodium intakes will be calculated. Skin and muscle sodium stores will be non-invasively quantified using 23sodium-magnetic resonance imaging (23Na-MRI).
次要结局
- Racial differences in concentrations of sodium in skin, muscle and bone(60 days)
- Racial differences in concentration of urinary potassium excretion(60 days)
研究者
Cheryl Anderson
Professor / Dean
University of California, San Diego