UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050255 |
|---|---|
| Receipt number | R000057181 |
| Scientific Title | Effect of Kaempferia parviflorar on aging in healthy adults in a randomized, double-blind, placebo-controlled double-blind parallel-group comparison study |
| Date of disclosure of the study information | 2023/04/03 |
| Last modified on | 2023/02/06 18:38:04 |
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Basic information
Public title
Effect of Kaempferia parviflora on aging in healthy adults
Acronym
Effect of Kaempferia parviflora on aging in healthy adults
Scientific Title
Effect of Kaempferia parviflorar on aging in healthy adults in a randomized, double-blind, placebo-controlled double-blind parallel-group comparison study
Scientific Title:Acronym
Effect of Kaempferia parviflora on aging in healthy adults in a randomized, double-blind, placebo-controlled double-blind parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the effects of Kaempferia parviflora on aging.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the cognitive function
Key secondary outcomes
To evaluate the height, weight, body composition, abdominal circumference, lower leg circumference, grip strength, vision, hearing, muscle strength, gait, blood test, urine test, BDNF, vascular endothelial function test, bone density test, tear fluid volume, saliva volume, skin test, questionnaire
We will compare measurements before intake, 6 weeks after intake, and 12 weeks after intake between each group.
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
Subjects receive 100 mg/day of Kaempferia parviflora for 12 weeks.
Interventions/Control_2
Subjects receive placebo 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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects who meet all of the following criteria will be included in the study
1) The subject must have received a full explanation of his/her participation in this study, and must have given written consent of his/her own free will based on a thorough understanding of the subject's situation.
2) Healthy men and women who are 45 years of age or older at the time consent is obtained.
3) Those with an MMSE-J score of 24 or higher at screening.
Key exclusion criteria
Research subjects who are in conflict with any of the following will not be included in this study
1) Those who consume health foods that may affect clinical research.
2)Those who have been exercising for at least one hour daily for at least six months on a continuous basis.
3)Those who have an irregular rhythm of life due to night shift work, shift work, etc.
4) Those who have extremely irregular eating, sleeping, and other lifestyle habits.
5) Those with color blindness
6) Those with a history of treatment for malignant tumors, heart failure, or myocardial infarction.
7) Persons under treatment for the following chronic diseases
Atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases
8)Persons suffering from dementia
9) Persons under treatment for or with a history of psychiatric disorders
10)Persons who regularly use pharmaceuticals (including herbal medicines)
11) Have allergies (to pharmaceuticals or food related to the tested food (squid))
12)Currently participating in other clinical research or clinical trials, or have participated in other clinical research or clinical trials within the past 3 months.
13)Pregnant, lactating, or intending to become pregnant
14) Other subjects deemed inappropriate for this study by the investigator.
Rationale 1) to 5) Influence on efficacy evaluation, 6) to 14) Safety considerations
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-3815-5411
igarashi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-3815-5411
Homepage URL
igarashi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Others
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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo Bunkyo-ku
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2023 | Year | 04 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057181
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