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临床试验/NCT04073719
NCT04073719Unknown不适用

Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

United States Naval Medical Center, San Diego0 个研究点目标入组 50 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Apple Cider Vinegar Urinary Citrate Increase

研究概览

简要总结

The purpose of this study is to assess whether certain beverages can increase urinary citrate levels in healthy individuals with no history of kidney disease.

详细描述

Higher urinary citrate levels have been shown to decrease one's risk of developing kidney stones. The study will compare apple cider vinegar, coconut water, diet citric soda and lemonade and determine which is superior at raising citrate levels. Research participants will consume two of the four drinks, each for 7 day periods, according to a prescribed regimen. Throughout the course of the study, participants will periodically provide blood draws for metabolic panels, as well as 24-hour urine samples to measure citrate levels. There will be 12 study arms, accounting for the permutations of two drinks for each patients out of four possibilities. 3 participants per arm is the goal, for a total of 36, but the recruitment aim is 50 participants, to account for dropout and noncompliance.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female volunteers 18-65 years old

排除标准

  • History of peptic ulcer disease or gastroparesis
  • Pregnant females
  • History of chronic kidney disease
  • History of urolithiasis
  • Currently taking medications that interfere with urinary electrolyte excretion (thiazide and loop diuretics)javascript:document.
  • History of Diabetes

研究组 & 干预措施

Coconut Water + Apple Cider Vinegar

Experimental

Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

干预措施: Apple Cider Vinegar (Dietary Supplement)

Apple Cider Vinegar + Lemonade

Experimental

Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

干预措施: Apple Cider Vinegar (Dietary Supplement)

Citric Soda + Apple Cider Vinegar

Experimental

Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

干预措施: Apple Cider Vinegar (Dietary Supplement)

Lemonade + Coconut Water

Experimental

Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Lemonade + Citric Soda

Experimental

Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Coconut Water + Citric Soda

Experimental

Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Coconut Water + Lemonade

Experimental

Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Citric Soda + Apple Cider Vinegar

Experimental

Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Citric Soda + Coconut Water

Experimental

Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Citric Soda + Lemonade

Experimental

Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

干预措施: Other Beverage (Dietary Supplement)

Lemonade + Apple Cider Vinegar

Experimental

Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

干预措施: Apple Cider Vinegar (Dietary Supplement)

Apple Cider Vinegar + Citric Soda

Experimental

Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

干预措施: Apple Cider Vinegar (Dietary Supplement)

Apple Cider Vinegar + Coconut Water

Experimental

Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

干预措施: Apple Cider Vinegar (Dietary Supplement)

结局指标

主要结局

Apple Cider Vinegar Urinary Citrate Increase

时间窗: 1 week

Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet

次要结局

  • Apple Cider Vinegar and urinary pH(1 week)
  • Palatability Evaluation(4 weeks)
  • Apple Cider Vinegar Against Other Beverages(4 weeks)

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Christine Herforth

Urology Resident

United States Naval Medical Center, San Diego

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