UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055261 |
|---|---|
| Receipt number | R000063145 |
| Scientific Title | Effects of intake of a food containing Kaempferia parviflora extract on blood metabolome |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2025/05/02 10:59:48 |
* 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
Effects of intake of a food containing Kaempferia parviflora extract on blood metabolome
Acronym
Effects of intake of a food containing Kaempferia parviflora extract on blood metabolome
Scientific Title
Effects of intake of a food containing Kaempferia parviflora extract on blood metabolome
Scientific Title:Acronym
Effects of intake of a food containing Kaempferia parviflora extract on blood metabolome
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for effect of blood metabolome when supplementation with Kaempferia parviflora extract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood metabolome
Key secondary outcomes
Blood sample analysis
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese males aged 20-59 years.
2) Subjects who are healthy.
3) Subjects who exercise intensely once a week or less.
4) Subjects who are able to be taken blood sample multiple times.
5) Subjects who fully understand this study and consent in this study with written.
6) Subjects whose BMI are 25.0-29.9.
Key exclusion criteria
1) Subjects who have Chronic illness or disability in the liver, biliary tract, gastrointestinal tract, circulatory system, respiratory system, kidney, urinary system, mental, nervous and blood system.
2) Subjects who participate in other clinical study within one month prior to the date of consent this study, or who plan to participate in other study during this study period.
3) Subjects who may develop allergies to the test food.
4) Subjects with severe anemia.
5) Subjects who are under visiting hospital, medication, treatment.
6) Subjects who are judged as ineligible for the subject of this study from doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tagawa |
Organization
Maruzen Pharmaceuticals Co., Ltd.
Division name
Research Center
Zip code
729-3102
Address
1089-8 Sagata Shinichi-Cho Fukuyama-City Hiroshima Japan
TEL
0847-52-5501
t-tagawa@maruzenpcy.co.jp
Public contact
Name of contact person
| 1st name | Rikiya |
| Middle name | |
| Last name | Shiwaku |
Organization
Maruzen Pharmaceuticals Co., Ltd.
Division name
Research Center
Zip code
729-3102
Address
1089-8 Sagata Shinichi-Cho Fukuyama-City Hiroshima Japan
TEL
0847-52-5501
Homepage URL
r-shiwaku@maruzenpcy.co.jp
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
芝パレスクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 19 | 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
| 2024 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063145
