Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Urinary mineralocorticoid receptor-regulated mRNA biomarker
研究概览
简要总结
This cross-over clinical trial is being conducted to evaluate the difference in urinary messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a low-sodium diet, as compared to a high-sodium diet. The study team will collect urine and blood samples from each participant to study mineralocorticoid receptor-regulated mRNA biomarkers following the consumption of each diet.
The study team will instruct the participants to consume 8 days each of high- (300 mmol/day) and low- (10 mmol/day) sodium meals. The order in which the participants will eat the two study diets will be randomly determined. In between the high- and low-sodium diets, the participants will have a wash-out period of 6 days, during which they will be encouraged to consume their usual diet. Participants will be asked to provide the study team with 24-hour urine samples, random urine samples, and blood samples throughout their participation in this clinical trial.
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
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normotensive, as defined by:
- •Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg
- •Never prescribed an antihypertensive medication
- •Willingness to refrain from intense exercise (for example, swimming, biking, running)
排除标准
- •Hypertension (history of blood pressure ≥ 140/90 mmHg)
- •History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension
- •History of chronic kidney disease
- •History of heart failure
- •Current food allergy
- •Pregnancy
- •Known hyperaldosteronism
- •Current mineralocorticoid antagonist use
- •Current treatment for diabetes mellitus
- •Known adrenal insufficiency
- •Current glucocorticoid use
- •Electrolyte abnormality on baseline laboratory assessment
- •Current potassium supplementation
- •Urinary tract infection (UTI)
- •Significant renal insufficiency or any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study
结局指标
主要结局
Urinary mineralocorticoid receptor-regulated mRNA biomarker
时间窗: Day 29 (after second diet period)
Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR).
Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker
时间窗: Day 15 (after first diet period)
Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR).
次要结局
- Blood pressure(Day 29 (after second diet period))
研究者
J Brian Byrd, MD, MS
Assistant Professor of Internal Medicine
University of Michigan