UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048305 |
|---|---|
| Receipt number | R000055049 |
| Scientific Title | Investigation on the Metabolic Regulation, Anti-inflammatory and Antioxidant Effects of Kaempferia Parviflora Extract to Exercise |
| Date of disclosure of the study information | 2022/07/08 |
| Last modified on | 2024/07/07 17:31:05 |
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Basic information
Public title
Investigation on the Metabolic Regulation, Anti-inflammatory and Antioxidant Effects of Kaempferia Parviflora Extract to Exercise
Acronym
Exercise Kaempferia Parviflora trial
Scientific Title
Investigation on the Metabolic Regulation, Anti-inflammatory and Antioxidant Effects of Kaempferia Parviflora Extract to Exercise
Scientific Title:Acronym
Exercise Kaempferia Parviflora trial
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of Kaempferia parviflora extract intake in healthy subjects on physiological function.
Basic objectives2
Others
Basic objectives -Others
Human subjects take Kaempferia parviflora extract or a placebo once daily (75mgmicromol/capsule /day) for 2 months. After that, a washout period of one month is provided, and the subjects are crossed over and ingest for another 2 months. Blood and urine will be collected before and after exercise to evaluate the antioxidant and anti-inflammatory effects caused by Kaempferia parviflora extract.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximal oxygen uptake (2 months after the administration)
Key secondary outcomes
biochemical indices, oxidative stress, inflammatory responses
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Human subjects ingest Kaempferia parviflora extract once a day (75mg micromol/capsule/day) for 2 months.
Interventions/Control_2
Subjects ingest placebo once a day (75mg micromol/capsule/day) for 2 months.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals
Key exclusion criteria
Abnormal findings on resting 12-lead electrocardiogram and/or blood pressure, Cannot limit drinking the day before the experiment, Smoking or taking antioxidant supplements, Taking anti-allergy agent or anti-inflammatory agent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa
TEL
04-2947-6898
katsu.suzu@waseda.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa
TEL
04-2947-6898
Homepage URL
katsu.suzu@waseda.jp
Sponsor or person
Institute
Waseda University
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
Office of Research Ethics, Waseda University
Address
1-104 Totsuka-cyo, Shinjyuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 07 | Month | 08 | 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
| 2022 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055049
