NCT02649140

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

December 1, 2015

Enrollment Period

3 months

First QC Date

December 31, 2015

Last Update Submit

January 5, 2016

Conditions

Urolithiasis

Keywords

24-hour urineCalcium oxalateVinegar

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Change of blood biochemical parameters

    One day before drinking vinegar(the 0th day)and on the 29th day after drinking vinegar.

Other Outcomes (1)

  • Change of blood oxidative stress markers

    One day before drinking vinegar(the 0th day) and on the 29th day after drinking vinegar.

Study Arms (2)

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.

Dietary Supplement: Vinegar group

Interventions

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.

Group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal renal function.
  • Those without urolithiasis
  • Those without congenital urinary tract abnormalities.

You may not qualify if:

  • Those with hematuria
  • Those with urinary tract infection
  • Those have a history of kidney or urinary diversion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 18093343BACKGROUND

  • 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. No abstract available.

    PMID: 20103553BACKGROUND

  • 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.

    PMID: 20109192BACKGROUND

  • 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. doi: 10.1271/bbb.64.1909.

    PMID: 11055395BACKGROUND

  • 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. doi: 10.1271/bbb.65.2690.

    PMID: 11826965BACKGROUND

  • 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.

    PMID: 20068289BACKGROUND

  • 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.

    PMID: 26064976BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Guohua Zeng, PH.D and M.D

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Guohua Zeng, PH.D and M.D

CONTACT

+86 13802916676gzgyzgh@vip.tom.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of the Hospital

Study Record Dates

First Submitted

December 31, 2015

First Posted

January 7, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 7, 2016

Record last verified: 2015-12

Locations

CN(1)