UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009439 |
|---|---|
| Receipt number | 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 | 2024/06/08 10:58:56 |
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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
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
kazuhisa-tky@umin.ac.jp
Sponsor or person
Institute
Department of Metabolism, Diabetes and Nephrology, Fukushima Medical University, Aizu Medical Center
Institute
Department
Personal name
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
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
NA
Publication of results
Published
Result
URL related to results and publications
https://confit.atlas.jp/guide/event/endo (The 89th annual meeting of the Japanese Endocrine Society)
Number of participants that the trial has enrolled
50
Results
A comparison between the previous study and the single-dose study disclosed no significant differences in outcome measures. A comparison between the previous study and the long-term administration study showed no significant differences as well. However, when analyzed in subjects with a HOMA-IR of 1.6 or 2.0 or higher, there was a significant difference in the reduction in total insulin and total insulin level x total blood glucose level.
Results date posted
| 2024 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Due to the time required to finalise the final results.
Date of the first journal publication of results
Baseline Characteristics
50 healthy adults aged 35 years and over without diabetes or other serious complications
Participant flow
As a pre-test, after blood and urine samples were taken, 150 ml of water was ingested followed by a test meal (600 ml of Lacol for males and 400 ml for females), and venous blood samples were taken 30, 60, 90, 120 and 240 minutes later. Next, as a single-dose study, within one to two weeks after the end of the previous study, 150 ml of vinegar water prepared by diluting apple cider vinegar 10-fold was ingested after the blood sample was taken, followed by the same test diet as in the previous study, and blood samples were taken 30, 60, 90 and 120 minutes later. Subsequently, as a long-term administration study, 30 ml of vinegar water was ingested twice daily before meals for 3-4 weeks, followed by the same tests as in the previous study.
Adverse events
No serious adverse events were observed. Abdominal pain was observed in one patient in the long-term study, but it was a single occurrence and the causal relationship was unclear. One person who offered that long-term intake would be difficult was only included in the single-dose study. Two cases in which blood samples could not be taken at the prescribed time were excluded, resulting in an analysis with 47 subjects.
Outcome measures
The difference between fasting blood glucose and peak blood glucose after taking the test meal, the area of the blood glucose curve, the sum of blood glucose level, the sum of insulin level, total insulin level x total blood glucose level
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 19 | Day |
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
| 2024 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011091
