Improving Vascular Health Using Nutrition Education Aimed At Increasing Potassium Intake Versus Reducing Sodium Intake
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in dietary sodium intake
研究概览
简要总结
The goal of this clinical trial is to determine if a self-selected high potassium diet is easier to achieve and more effective at improving vascular health than a low sodium diet in generally healthy young adults who typically consume more than the recommended amount of sodium. The main questions it aims to answer are:
- Is it easier for young adults to increase their potassium intake, rather than reduce their sodium intake?
- Is a self-selected high potassium diet better at improving vascular health compared to a self-selected low sodium diet?
Researchers will compare the effectiveness of an education-based intervention centered only on increasing dietary potassium intake against an education-based intervention centered only on reducing dietary sodium intake.
Participants will be randomly assigned to receive comprehensive dietary education on adopting either a high-potassium diet or a low-sodium diet.
Education will be delivered in four weekly one-on-one sessions. Following the four-week education period, participants will be encouraged to change their diet based on what they have learned. Measures of dietary compliance (urine samples and diet records) and cardiovascular health (blood pressure, endothelial function) will be assessed at two, four, and six months post-education.
详细描述
High sodium diets are a major contributor to cardiovascular disease. Unfortunately, reducing sodium intake can be challenging. It is known that increasing potassium intake can improve cardiovascular disease risk factors in a laboratory setting. The investigators are hoping to show that it is more feasible and effective for individuals to increase their potassium intake, rather than reduce their sodium intake, to improve cardiovascular disease risk factors, including blood pressure and endothelial function.
In this study, participants will be randomly assigned to receive individualized education over the course of four weeks to help them adopt one of two dietary patterns: 1) a self-selected low sodium diet (goal: ≤1,500 mg/day) or 2) a self-selected high potassium diet (goal: ≥4,700 mg/day). Participants will be provided individualized nutrition education once per week, at the participant's convenience by trained study staff to help them meet the target nutrition goals. No food, supplements, or devices will be provided to participants, and participants will be advised not to take any dietary supplements containing potassium during the intervention and follow-up period. Follow up with participants will be every two months for six months post-education to measure compliance with the desired dietary changes as well as changes in cardiovascular 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to attend in-person laboratory visits
- •Usual sodium intake ≥3,000 mg/d for females and ≥4,000 mg/d for males
- •Usual potassium intake ≤2,500 mg/d in females and ≤3,000 mg/d in males
排除标准
- •BMI ≥35 kg/m2
- •Seated blood pressure ≥130/80 mmHg
- •Current diagnosis or history of diabetes, renal disease, cancer, cardiovascular disease, or major cardiovascular event (e.g. heart attack or stroke)
- •Current or recent use of a diuretic (within the past 6 months)
- •Elevated blood lipids (LDL cholesterol ≥190 mg/dL)
- •Elevated serum potassium level (>5.1 mmol/L)
- •Elevated BUN (>22 mg/dL)
- •Elevated creatinine (>1.2 mg/dL)
- •Low eGFR (<90 mL/min/1.73 m²)
- •Current or recent use of tobacco, nicotine, or illicit drugs
- •Radical hysterectomy or oophorectomy (females)*
- •Pregnant or lactating
- •Following a weight-loss diet, or intending to gain or lose weight during the study period
研究组 & 干预措施
High potassium dietary education
干预措施: High potassium dietary education/counseling (Behavioral)
Low sodium dietary education
干预措施: Low sodium dietary education/counseling (Behavioral)
结局指标
主要结局
Change in dietary sodium intake
时间窗: Baseline; 2 month, 4month, 6month
Dietary sodium intake will be assessed via participant self-reported 3 day diet record
Change in dietary potassium intake
时间窗: Baseline, 2month, 4month, 6month
Dietary potassium intake will be assessed via participant self-reported 3-day diet record
Change in 24-hour urinary sodium excretion
时间窗: Baseline, 2month, 4month, 6month
Urinary sodium excretion obtained from 24-hour urine sample
Change in 24-hour urinary potassium excretion
时间窗: Baseline, 2month, 4month, 6month
Urinary potassium excretion measured from 24-hour urine sample
Change in Blood pressure
时间窗: Baseline; 2 month, 4month, 6month
Seated, automated blood pressure mmHg
Change in Endothelial function
时间窗: Baseline; 2 month, 4month, 6month
brachial artery flow-mediated dilation as measured in % dilation
次要结局
- Indirect measurement of arterial stiffness(Baseline, 2month, 4month, 6month)
- Direct measurement of arterial stiffness(Baseline, 2month, 4month, 6month)
研究者
Andrea Lobene
Assistant Professor
Florida State University