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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009439
Receipt No. R000011091
Scientific Title Effect of vinegar ingestion on the postprandial plasma glucose changes after the intake of semi-digested nutrition agent
Date of disclosure of the study information 2012/11/30
Last modified on 2019/06/05

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Basic information
Public title Effect of vinegar ingestion on the postprandial plasma glucose changes after the intake of semi-digested nutrition agent
Acronym Effect of vinegar on the plasma glucose levels
Scientific Title Effect of vinegar ingestion on the postprandial plasma glucose changes after the intake of semi-digested nutrition agent
Scientific Title:Acronym Effect of vinegar on the plasma glucose levels
Region
Japan

Condition
Condition Diabetes Mellitus, Impaired Glucose Tolerance
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the effects of single vinegar ingestion and long term continuous vinegar ingestion on the postprandial plasma glucose changes after taking semi-digested nutrition agent in healthy volunteers. We also examine whether the plasma triglyceride levels and parameters associated with metabolic diseases would be modulated with the long term vinegar ingestion.
This study would clarify that administration of vinegar water ahead of semi-digested nutrition agent in patients under tube-feeding possesses beneficial effect on the glycemic control. In addition, the results of long term study disclose whether the daily ingestion of vinegar water in diabetic patient would be beneficial or not.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Plasma glucose levels, insulin, CPR, HbA1c, BMI, waist circumference, triglycerides
Key secondary outcomes adiponectin, markers for oxidative stress, markers associated with metabolic diseases

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Single vinegar administration test: After drinking 150ml vinegar water (10 times-diluted vinegar), plasma glucose, insulin and CPR levels are measured sequentially up to 120 min after taking semi-digested nutrition agent. These values are compared with those without taking vinegar water.
Long term vinegar administration test: After taking 150 ml vinegar water twice daily before meals for 3 to 4 weeks, the subject takes semi-digested nutrition agent, and plasma glucose, insulin and CPR levels are measured sequentially up to 120 min. These values are compared with those examined before the subjects begin to take vinegar water. In addition, changes in several markers associated with metabolic diseases, for example plasma TG and adiponectin levels, are also examined. To analyze the safety of vinegar water ingestion, liver, renal functions as well as urine tests are examined.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Healthy volunteer
2) Those who do not suffer from diabetes mellitus (HbA1c (NGSP) less than 6.5%, and FBS less that 126 mg/dL)
Key exclusion criteria 1) Those who suffer from serious diseases (for example, liver disease, renal disease, heart disease, etc.)
2) Those who are pregnant, in breast-feeding, or have a probability of pregnancy.
3) Those who cannot drink vinegar water.
4) Those who are judged not to be appropriate for this study by the physicians.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Tsukamoto
Organization Aizu General Hospital, Fukushima Medical University Aizu Medical Center
Division name Department of Metabolism, Diabetes and Nephrology
Zip code 969-3492
Address 21-2 Maeda, Tanizawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL +81-242-75-2100
Email kazut@fmu.ac.jp

Public contact
Name of contact person
1st name Kazuhisa
Middle name
Last name Tsukamoto
Organization Fukushima Medical University Aizu Medical Center
Division name Department of Metabolism, Diabetes and Nephrology
Zip code 969-3492
Address 21-2 Maeda, Tanizawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL +81-242-75-2100
Homepage URL
Email kazuhisa-tky@umin.ac.jp

Sponsor
Institute Department of Metabolism, Diabetes and Nephrology, Fukushima Medical University, Aizu Medical Center
Institute
Department

Funding Source
Organization Fukushima Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aizu Medical Center, Fukushima Medical University
Address 21-2 Maeda, Tanizawa, Kawahigashi, Aizuwakamatsu City, Fukushima
Tel 0242-27-2151
Email aidusougou.byouin@pref.fukushima.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福島県立会津総合病院(福島県)、福島県立医科大学会津医療センター

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 04 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 29 Day
Last modified on
2019 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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