The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Seated Blood Pressure
研究概览
简要总结
This study will examine the effects of low sodium meal plan on seated blood pressure in older adults from a community-based, congregate senior living facility.
详细描述
Hypertension in older adults is a known contributor to both cardiovascular disease and falls. The Centers of Disease Control advocates for low sodium, senior meal plans as a strategy to lower blood pressure (BP). However, sodium is recommended to treat orthostatic hypotension (OH), a risk factor of falls. The long-term effects of low sodium intake on physical function are largely unknown in older adults.
The objective of this proposed pilot study is to determine the feasibility of an individual-level, randomized feeding study that examines the impact of sodium reduction on BP regulation among 40 semi-independent, older adults aged 60 and above.
Primary Aim 1: To determine the effects of a low sodium (<0.9 mg per kcal of energy intake), 2-week meal plan compared with a usual meal plan (average sodium ~2 mg per kcal of energy intake) on seated BP among independently living older adults.
Hypothesis Aim 1: Compared with the usual meal plan, a reduced sodium meal plan will lower seated BP in older adults after 2 weeks.
Feasibility Aim 1: To evaluate the recruitment experience, meal cost, meal delivery logistics, and compliance with and tolerability of the meal plan (urine sodium and palatability questionnaires).
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, Investigator, Outcomes Assessor)
盲法说明
Study staff involved in administering the dietary intervention and assessing compliance will be masked to participants' outcome assessments (e.g. BP).
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident at Jack Satter House in Revere
- •Age >= 60 years
- •Resting systolic blood pressure 100-149 mm Hg and diastolic blood pressure <100 mm Hg
- •Stable BP medications (no recent or intended changes)
排除标准
- •Cognitive Impairment (Montreal Cognitive Assessment test <18)
- •Unstable blood pressure medications in the past 2 months
- •Terminal or mental illness
- •Severe allergies to common foods
- •Unwillingness to comply with the diet
- •Physical inability to do a timed up and go test
- •Active kidney dialysis or history of kidney transplant
结局指标
主要结局
Seated Blood Pressure
时间窗: 2 weeks
Average of three seated systolic and diastolic blood pressure readings
次要结局
- Orthostatic Hypotension(2 weeks)
研究者
Shivani Sahni
Associate Scientist
Hebrew SeniorLife