UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050954 |
|---|---|
| Receipt number | R000057884 |
| Scientific Title | Trial of efficacy of ellagic acid in Japanese |
| Date of disclosure of the study information | 2024/09/10 |
| Last modified on | 2023/12/14 10:44:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Trial of efficacy of ellagic acid in Japanese
Acronym
Trial of efficacy of ellagic acid in Japanese
Scientific Title
Trial of efficacy of ellagic acid in Japanese
Scientific Title:Acronym
Trial of efficacy of ellagic acid in Japanese
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the body fat reduction effect and safety when healthy men and women continuously ingested the test food for 12 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area (VFA) and amount of change
Key secondary outcomes
1)Abdominal subcutaneous fat area (SFA) and amount of change
2)Abdominal total fat area (TFA) and amount of change
3)Body fat ratio and amount of change
4)Triglycerides and amount of change
5)Body weight and amount of change
6)BMI and amount of change
7)Waist circumference and amount of change
8)Hip circumference and amount of change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test food (capsules containing ellagic acid) for 12 weeks
Interventions/Control_2
Intake the control food (capsules without ellagic acid) for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females between the ages of 20 and less than 65 at the time of obtaining consent to participate in the test
2)Healthy persons who are not currently being treated for any illness
3)Those who have a BMI of 25 or more but less than 30 (Level 1 Obesity) at screening
4)Those who can visit the designated facility on the scheduled visit date
5)Those who fully understand the purpose and content of this test and have agreed in writing
Key exclusion criteria
1)Those who have difficulty to participate in this study because of conditions i.e., liver, kidney, or cardiac disease, breathing, endocrinology, metabolism, nervous, or conscious disorder, diabetes (determined by JDA), and other diseases
2)Those with history of cardiovascular diseases
3)Those who take drugs to improve glucose metabolism, lipid metabolism, or blood pressure
4)Those who use medicines, health foods and supplements (including "Food for specified health uses", "Foods with function claims" and "Food with nutrient function claims") constantly, excepting those who can stop them at taking of informed consent
5)Those who have allergies related to test food
6)Previous experience of poor or worsened health after giving a blood sample
7)Those who have donated at least 200 mL of blood from 3 months prior to the start of the test to the start of the test, or those who plan to do so during the test period
8)Participating in another clinical trial or within 4 weeks of completion of the trial
9)Heavy alcohol drinkers and excessive smokers
10)Those with extremely irregular eating habits
11)Those who wish to become pregnant, pregnant women (including those who may be pregnant), or lactating mothers during the study period
12)Those who do not agree with the purpose of the explanation of this examination given prior to the examination
13)Those who are deemed by the investigator to be inappropriate to participate in this study
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Division
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Kyowa Trial Co., Ltd.
Institute
Department
Personal name
Yoshimichi Kozai
Funding Source
Organization
Ryusendo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Yamazaki Otolaryngology Vertigo Clinic
Address
14-1-16 Kita 11-jo Nishi, Chuo-ku, Sapporo-shi, Hokkaido 060-0011, Japan
Tel
011-757-3387
s-ito@kyowa-t.com
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
LSI札幌クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057884
