Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Uric Acid Level
研究概览
简要总结
Unhealthy diet has long been associated with high uric acid levels and gout. The DASH diet may lower uric acid levels. This study will examine the effects of the DASH diet on uric acid in adults with a history of gout.
详细描述
The public health burden of gout is substantial. Several lines of evidence suggest that a DASH diet might lower uric acid. However, there are no trials of the DASH diet in adults with gout. This trial is a cross-over study of the effects of a DASH-like diet on uric acid in adults with gout and hyperuricemia, who are not taking urate-lowering therapy.
Perpetuated by the "Western" lifestyle and resulting obesity epidemic, the prevalence of gout has increased over the past few decades to 3.9% of US adults (8.3 million individuals). This prevalence increases with age to 9.3% of US adults over 60 years (4.7 million).
Participants will be community-dwelling adults, aged 18+ with a baseline serum uric acid level of 7 mg/dL, who have a self-reported history of gout and are not taking urate lowering medications (e.g. allopurinol, febuxostat, probenecid).
This trial is comprised of two study periods: (1) a dietitian-directed diet (DD) or (2) self-directed usual diet (SD). Each period lasts 4 weeks. All participants will participate in both periods, but half will undergo the dietitian-directed diet first while the other half will undergo the self-directed diet first. During the dietitian-directed diet, participants will receive $105/week of foods in a pattern that conforms to the DASH diet. The DASH diet emphasizes fruit, vegetables, lean meat, low fat dairy, and high fiber, while restricting red meat, sweets, and sugary beverages. During the self-directed diet, participants will be asked to eat their typical diet outside of the study. Investigators anticipate 40 participants in this study.
The primary outcome is uric acid. Secondary outcomes of this study include: body mass index, systolic and diastolic blood pressure, fasting cholesterol, and fasting blood glucose. Both primary and secondary outcomes will be measured 3 times: (1) before the study begins (baseline), (2) after period 1 (at 4 weeks), and (3) after period 2 (at 8 weeks). Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed throughout the study as well.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators will not know which assignment the participants were given. The laboratory measuring uric acid will not know which intervention the participants were assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18-100 years
- •Self-reported gout diagnosis
- •Serum Uric Acid > 7 mg/dL
排除标准
- •Recent or planned changes to urate lowering therapies (e.g. allopurinol, febuxostat, probenecid)
- •Recent or planned changes to hypertension, lipid, or diabetes medications
- •Patients with hyperkalemia (>5 mmol/L)
- •Chronic kidney disease (GFR < 30 cc/min), kidney transplant, dialysis
- •Gastro-intestinal conditions (e.g. history of gastric bypass surgery, active inflammatory bowel disease, malabsorption, or major GI resection)
- •Active cancer treatment (e.g. radiation or chemotherapy)
- •Diagnosis of any of the following in the past 6 months: heart attack, heart failure, angina, coronary bypass or angioplasty, or Chronic Obstructive Pulmonary Disease (COPD)
- •Alcohol use over 14 drinks per week
- •Inability to give informed consent
- •Active use of warfarin, insulin, or chronic steroids (like prednisone)
- •Terminal or mental illness
研究组 & 干预措施
Dietitian-Directed Diet
Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.
干预措施: Subsidy for food purchases and dietitian education (Other)
Self-Directed Diet
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
结局指标
主要结局
Uric Acid Level
时间窗: At 8-weeks
Measured in serum
Uric Acid Level
时间窗: Baseline
Measured in serum
Uric Acid Level
时间窗: At 4-weeks
Measured in serum
次要结局
- Body Mass Index (kg/m^2)(Baseline, 4-weeks, 8-weeks)
- Systolic Blood Pressure (mm Hg)(Baseline, 4-weeks, 8-weeks)
- Diastolic Blood Pressure (mm Hg)(At baseline, 4-weeks, 8-weeks)
- Fasting Blood Glucose (mg/dL)(Baseline, 4-weeks, 8-weeks)
- Low Density Lipoprotein Cholesterol (mg/dL)(Baseline, 4-weeks, 8-weeks)