UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049193 |
|---|---|
| Receipt number | R000056035 |
| Scientific Title | Awamori luchuensis increases the longevity |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2022/10/12 01:32:58 |
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Basic information
Public title
Awamori raises HDL, reduces the onset of heart disease and cerebrovascular accidents, improves peripheral neuromuscular disorders and dementia, enhances the activities of daily living, and prevents the onset of infections increasing the longevity of the residents of Okinawa
Acronym
Awamori enhances the activities of daily living.
Scientific Title
Awamori luchuensis increases the longevity
Scientific Title:Acronym
the effect of Awamori luchuensis
Region
| Japan |
Condition
Condition
hyperlipidemia, heart disease, cerebrovascular accidents, peripheral neuromuscular disorders, dementia, infections, aged disease
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ryukyu Awamori is a distilled spirit that is produced solely in Okinawa since ancient times. Additionally, Okinawans are known to have the longest life expectancy in the world. To explore the effect of Awamori on Okinawans in a population-based study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The levels of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol and triglycerides were measured in 5161 outpatients who consumed Awamori. Additionally, heart disease, brain disease, virus infections, tumor morbidity, neuropathy improvement rate, and survival rate after rehabilitation were measured in 641 inpatients aged 80 over years who consumed Awamori for 20 years.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 A total of 5109 outpatients, age range, 3592 years, who visited the hospital for health checkup were included in the study.
2 A total of 674 inpatients, mean age, 88 years, age range, 81 98 years, were evaluated.
Key exclusion criteria
1 among them, 825 people who did not drink alcohol were excluded. Of the remaining 4284 outpatients who had a drinking habit, 1430 were excluded due to various factors. Of the remaining 2854 outpatients who were within the examination standard value, 755 people who exercised regularly were excluded. Subsequently, 1822 out of the remaining 2099 outpatients who had a drinking habit and did not exercise regularly were excluded because they consumed other alcoholic drinks such as wine, sake, beer, and whiskey. Finally, 277 outpatients who consumed only Awamori were included in this study, which was conducted over a period of 1 year from January to December 2019.
2 Among them, 31 were excluded because they did not belong to the Okinawa prefecture. Of the 643 remaining patients, 374 were excluded because they presented with the following conditions, unknown drinking history, unknown identity, untraceable duration, disagreement, alcoholism, thyroid disease, fractures, bedridden for 50% over of the day, inability to consume food orally, and inability to speak. Finally, the clinical findings, laboratory findings, and extent of rehabilitation were compared between 134 patients who consumed Awamori, less 1 gou almost every day for more than 20 years until admission, and 106 patients who did not Awamori, which was conducted over a period of 3 year from January to December 2019.
Target sample size
5783
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Gonda |
Organization
Daido Central Hospital
Division name
Surgery
Zip code
902-0067
Address
1-1-37 Daido, Naha, Okinawa
TEL
098-869-0005
gondake@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Gonda |
Organization
Daido Central Hospital
Division name
Surgery
Zip code
902-0067
Address
1-1-37 Daido, Naha, Okinawa
TEL
098-869-0005
Homepage URL
gondake@fmu.ac.jp
Sponsor or person
Institute
Daido Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Daido Central Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Daido Central Hospital
Address
1-1-37 Daido, Naha, Okinawa
Tel
098-869-0005
gondake@fmu.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 12 | 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
383
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
| 2019 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the present study aimed to investigate the relationship between Ryukyu Awamori and disease as well as longevity. The levels of HDL, LDL, TC, and TG were measured in patients who consumed Awamori. Additionally, the lipid values, incidence of cardio-vascular and cerebrovascular events as well as peripheral neuromuscular disorders, occurrence of dementia, and degree of improvement following rehabilitation were assessed.
Management information
Registered date
| 2022 | Year | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056035
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