UrolithiasisNCT02649140
Effect of Vinegar Consumption on 24-hour Urinary Risk Factors Associated With Stone Formation
A study testing Vinegar group in people with Urolithiasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Vinegar group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal renal function.
- Those without urolithiasis
- Those without congenital urinary tract abnormalities.
Who cannot join
- Those with hematuria
- Those with urinary tract infection
- Those have a history of kidney or urinary diversion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Guohua Zeng, Ph.D and M.D, +86 13802916676, gzgyzgh@vip.tom.com
Guohua Zeng, Ph.D and M.D
About this study
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.
Read more
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.
Read the detailed description
Purpose:
The written history of vinegar use in China was more than 5,000 years,and it was used as health care products since ancient times. In addition of the main component of acetic acid, it also contains other acids, esters, polyphenols and other active substances.Previous studies have reported some effects of vinegar, such as delays gastric emptying,relieves fatigue, regulates blood glucose and lipid metabolism, antioxidant, reduces blood pressure and so on. The China national epidemiological study of urolithiasis which was conducted from May 2013 through July 2014 indicated that vinegar may be protective against the formation of urolithiasis (has not been published). Animal experiments showed that vinegar could inhibit oxalate calcium crystal formation in rat kidneys (has not been published). Consequently, we performed this randomized controlled trial 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:
Study design and participants: We will recruit 50 healthy young student volunteers in this study. The inclusion criteria are male who age 18-35 years, and those with normal renal function,without urolithiasis and congenital urinary tract abnormalities. The exclusion criteria include hematuria, urinary tract infection and have a history of kidney or urinary diversion. We exclude male older than 35 years because usually they have to work and not easy to collect 24-hour sample. The reason of excluding female is that the trail will last four weeks and women's menstrual cycle could affect 24-hour urine collection.
Randomisation:
Trained research clinicians enroll volunteers in a university nearby our hospital. Volunteers will be allocated in a 1:1 ratio to control group(group 1) or vinegar group(group 2) by simple random sampling technique, which is conducted by clinical trial office in urology department of our hospital in Guangzhou, China.
Procedures: Each participant in vinegar group drink 15ml vinegar ( Ninghuafu, Sanxi, China) after dinner at noon and evening respectively for a period of four weeks,and participants in control group do not need intervention.All of participants drink vinegar under the surveillance of research clinicians.
Data collection:
Baseline data will be collected before randomization in our hospital. The baseline data protocol includes urinary ultrasonography, spot urine examines, 24-hour urine analysis and blood chemical examines. The parameters of 24-hour urine analysis include Ph, volume, creatinine, oxalate, citrate, phosphate, uric acid, calcium, magnesium, sodium and chloride. The standard blood analysis protocol included routine haematology, fasting serum glucose, creatinine, urea, uric acid, high-density lipoprotein, low-density lipoprotein, triglycerides, alanine transaminase(ALT), total protein(TP), albumin, glutamyltransferase (GGT) , serum total bile acid, cholesterol, sodium, potassium, calcium and chloride ions. Another tube of blood samples are freeze in -80 degree refrigerator for further analysis of oxidation of blood protein product(AOPP), malondialdehyde(MDA), glutathion peroxidase(GSH-PX), superoxide dismutase(SOD) and catalase activity(CAT).
Follow-up data include 24-hour urine analysis on the 7th, 14th, 21th and 28th day during this period and blood biochemical examines on the 29th day. The protocol of 24-hour urine and blood chemical examines is the same with baseline data. And participants will be asked to make a record of meals for seven days.The ANOVA for repeated measures is used to perform the data analysis.
- Conditions
- Urolithiasis
- Being tested
- Vinegar group
- Keywords
- 24-hour urine, Calcium oxalate, Vinegar
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinegar groupDietary supplement
Each participant in vinegar group drink 15ml vinegar(Ninghuafu,Sanxi,China)after dinner at noon and evening respectively for a period of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Group1 is control group and participants do not need intervention. |
| Group 2 | Experimental | Group 2 is vinegar Group and participants in this group are asked to drink 15ml vinegar(Ninghuafu, Sanxi, China)after dinner at noon and evening respectively for a period of four weeks. Receives: Dietary Supplement: Vinegar group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day before drinking vinegar(the 0th day)and on the 7th,14th,21th and 28th day after drinking vinegar.
Secondary outcomes (1)
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.
Measured: One day before drinking vinegar(the 0th day)and on the 29th day after drinking vinegar.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, PH.D and M.D, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649140
- Sponsor's protocol ID
- MRER(52)2015
- Status last verified
- Dec 2015
- First submitted
- 31 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hlebowicz J, Darwiche G, Bjorgell O, Almer 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. doi: 10.1186/1471-230X-7-46.
PubMed 18093343Mitrou 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. No abstract available.
PubMed 20103553Setorki 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.
PubMed 20109192Nishidai 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. doi: 10.1271/bbb.64.1909.
PubMed 11055395Kondo 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. doi: 10.1271/bbb.65.2690.
PubMed 11826965Johnston 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.
PubMed 20068289Mitrou 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.
PubMed 26064976
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vinegar Consumption on 24-hour Urinary Risk Factors Associated With Calcium Oxalate Urinary Stone Formation: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02649140
- Acronym / sponsor ID
- MRER(52)2015
- Conditions
- Urolithiasis
- Keywords
- 24-hour urine, Calcium oxalate, Vinegar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
The written history of vinegar use in China was more than 5,000 years,and it was used as health care products since ancient times. In addition of the main component of acetic acid, it also contains other acids, esters, polyphenols and other active substances.Previous studies have reported some effects of vinegar, such as delays gastric emptying,relieves fatigue, regulates blood glucose and lipid metabolism, antioxidant, reduces blood pressure and so on. The China national epidemiological study of urolithiasis which was conducted from May 2013 through July 2014 indicated that vinegar may be protective against the formation of urolithiasis (has not been published). Animal experiments showed that vinegar could inhibit oxalate calcium crystal formation in rat kidneys (has not been published). Consequently, we performed this randomized controlled trial 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:
Study design and participants: We will recruit 50 healthy young student volunteers in this study. The inclusion criteria are male who age 18-35 years, and those with normal renal function,without urolithiasis and congenital urinary tract abnormalities. The exclusion criteria include hematuria, urinary tract infection and have a history of kidney or urinary diversion. We exclude male older than 35 years because usually they have to work and not easy to collect 24-hour sample. The reason of excluding female is that the trail will last four weeks and women's menstrual cycle could affect 24-hour urine collection.
Randomisation:
Trained research clinicians enroll volunteers in a university nearby our hospital. Volunteers will be allocated in a 1:1 ratio to control group(group 1) or vinegar group(group 2) by simple random sampling technique, which is conducted by clinical trial office in urology department of our hospital in Guangzhou, China.
Procedures: Each participant in vinegar group drink 15ml vinegar ( Ninghuafu, Sanxi, China) after dinner at noon and evening respectively for a period of four weeks,and participants in control group do not need intervention.All of participants drink vinegar under the surveillance of research clinicians.
Data collection:
Baseline data will be collected before randomization in our hospital. The baseline data protocol includes urinary ultrasonography, spot urine examines, 24-hour urine analysis and blood chemical examines. The parameters of 24-hour urine analysis include Ph, volume, creatinine, oxalate, citrate, phosphate, uric acid, calcium, magnesium, sodium and chloride. The standard blood analysis protocol included routine haematology, fasting serum glucose, creatinine, urea, uric acid, high-density lipoprotein, low-density lipoprotein, triglycerides, alanine transaminase(ALT), total protein(TP), albumin, glutamyltransferase (GGT) , serum total bile acid, cholesterol, sodium, potassium, calcium and chloride ions. Another tube of blood samples are freeze in -80 degree refrigerator for further analysis of oxidation of blood protein product(AOPP), malondialdehyde(MDA), glutathion peroxidase(GSH-PX), superoxide dismutase(SOD) and catalase activity(CAT).
Follow-up data include 24-hour urine analysis on the 7th, 14th, 21th and 28th day during this period and blood biochemical examines on the 29th day. The protocol of 24-hour urine and blood chemical examines is the same with baseline data. And participants will be asked to make a record of meals for seven days.The ANOVA for repeated measures is used to perform the data analysis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Group1 is control group and participants do not need intervention. |
| Group 2 | Experimental | Dietary Supplement: Vinegar groupGroup 2 is vinegar Group and participants in this group are asked to drink 15ml vinegar(Ninghuafu, Sanxi, China)after dinner at noon and evening respectively for a period of four weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal renal function.
- Those without urolithiasis
- Those without congenital urinary tract abnormalities.
Key exclusion criteria (3 listed)
- Those with hematuria
- Those with urinary tract infection
- Those have a history of kidney or urinary diversion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinegar groupEach participant in vinegar group drink 15ml vinegar(Ninghuafu,Sanxi,China)after dinner at noon and evening respectively for a period of four weeks. | Dietary supplement | Group 2 |
Primary outcome
Change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation
Time frame: One day before drinking vinegar(the 0th day)and on the 7th,14th,21th and 28th day after drinking vinegar.
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.
1 secondary outcome
Change of blood biochemical parameters
Time frame: One day before drinking vinegar(the 0th day)and on the 29th day after drinking vinegar.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Background: PubMed 18093343Hlebowicz J, Darwiche G, Bjorgell O, Almer 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. doi: 10.1186/1471-230X-7-46.
- Background: PubMed 20103553Mitrou 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. No abstract available.
- Background: PubMed 20109192Setorki 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.
- Background: PubMed 11055395Nishidai 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. doi: 10.1271/bbb.64.1909.
- Background: PubMed 11826965Kondo 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. doi: 10.1271/bbb.65.2690.
- Background: PubMed 20068289Johnston 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.
- Background: PubMed 26064976Mitrou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guohua Zeng, PH.D and M.D study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vinegar group in people with Urolithiasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guohua Zeng, PH.D and M.D (+86 13802916676, gzgyzgh@vip.tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation (time frame: One day before drinking vinegar(the 0th day)and on the 7th,14th,21th and 28th day after drinking vinegar.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02649140, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.