Urolithiasis Clinical Trial
Official title:
The Effect of Vinegar Consumption on 24-hour Urinary Risk Factors Associated With Calcium Oxalate Urinary Stone Formation: a Randomised Controlled Trial
Purpose:
The aim of this present study is to investigate the effect of vinegar consumption on 24-hour
urinary risk factors associated with calcium oxalate urinary stone formation and blood
biochemical parameters.
Methods:
The investigators will recruit 50 healthy young student volunteers in this study. By simple
random sampling technique, volunteers will be allocated to two groups (group 1, control
group; group 2, vinegar group).Each participant in vinegar group drink 15ml vinegar (
Ninghuafu, Sanxi, China) at noon and evening respectively for a period of four weeks.The end
point of this study is comparison the outcomes of 24-hour urine and blood biochemical
parameters between different group and point-in-time.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Normal renal function. - Those without urolithiasis - Those without congenital urinary tract abnormalities. Exclusion Criteria: - Those with hematuria - Those with urinary tract infection - Those have a history of kidney or urinary diversion. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
China | Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Guangzhou Medical University |
China,
Hlebowicz J, Darwiche G, Björgell O, Almér LO. Effect of apple cider vinegar on delayed gastric emptying in patients with type 1 diabetes mellitus: a pilot study. BMC Gastroenterol. 2007 Dec 20;7:46. — View Citation
Johnston CS, Steplewska I, Long CA, Harris LN, Ryals RH. Examination of the antiglycemic properties of vinegar in healthy adults. Ann Nutr Metab. 2010;56(1):74-9. doi: 10.1159/000272133. — View Citation
Kondo S, Tayama K, Tsukamoto Y, Ikeda K, Yamori Y. Antihypertensive effects of acetic acid and vinegar on spontaneously hypertensive rats. Biosci Biotechnol Biochem. 2001 Dec;65(12):2690-4. — View Citation
Mitrou P, Petsiou E, Papakonstantinou E, Maratou E, Lambadiari V, Dimitriadis P, Spanoudi F, Raptis SA, Dimitriadis G. Vinegar Consumption Increases Insulin-Stimulated Glucose Uptake by the Forearm Muscle in Humans with Type 2 Diabetes. J Diabetes Res. 2015;2015:175204. doi: 10.1155/2015/175204. Epub 2015 May 6. — View Citation
Mitrou P, Raptis AE, Lambadiari V, Boutati E, Petsiou E, Spanoudi F, Papakonstantinou E, Maratou E, Economopoulos T, Dimitriadis G, Raptis SA. Vinegar decreases postprandial hyperglycemia in patients with type 1 diabetes. Diabetes Care. 2010 Feb;33(2):e27. doi: 10.2337/dc09-1354. — View Citation
Nishidai S, Nakamura Y, Torikai K, Yamamoto M, Ishihara N, Mori H, Ohigashi H. Kurosu, a traditional vinegar produced from unpolished rice, suppresses lipid peroxidation in vitro and in mouse skin. Biosci Biotechnol Biochem. 2000 Sep;64(9):1909-14. — View Citation
Setorki M, Asgary S, Eidi A, Rohani AH, Khazaei M. Acute effects of vinegar intake on some biochemical risk factors of atherosclerosis in hypercholesterolemic rabbits. Lipids Health Dis. 2010 Jan 28;9:10. doi: 10.1186/1476-511X-9-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of blood oxidative stress markers | To compare the change of blood oxidative stress markers which include blood protein product(AOPP),MDA,glutathion peroxidase(GSH-PX),superoxide dismutase(SOD) and catalase activity(CAT) before grouping and on the 28th day after drinking vinegar. | One day before drinking vinegar(the 0th day) and on the 29th day after drinking vinegar. | No |
Primary | Change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation | To compare the change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation which include Ph, volume, creatinine, oxalate, citrate, phosphate, uric acid, calcium, magnesium, sodium and chloride of 24-hour urine between two groups on the 7th,14th,21th and 28th day after drinking vinegar. | One day before drinking vinegar(the 0th day)and on the 7th,14th,21th and 28th day after drinking vinegar. | No |
Secondary | Change of blood biochemical parameters | To compare the change of blood biochemical parameters which include fasting serum glucose, creatinine, urea, uric acid, high-density lipoprotein, low-density lipoprotein, triglycerides,serum total bile acid, cholesterol, sodium, potassium, calcium and chloride ions before grouping and on the 28th day after drinking vinegar. | One day before drinking vinegar(the 0th day)and on the 29th day after drinking vinegar. | No |
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