UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048026 |
|---|---|
| Receipt number | R000054742 |
| Scientific Title | Effects of Kaempferia parviflora extract on body fat -Randomized, double-blind, placebo-controlled parallel group study- |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2023/06/14 08:28:32 |
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Basic information
Public title
Effects of Kaempferia parviflora extract on body fat -Randomized, double-blind, placebo-controlled parallel group study-
Acronym
Effects of Kaempferia parviflora extract on body fat
Scientific Title
Effects of Kaempferia parviflora extract on body fat -Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym
Effects of Kaempferia parviflora extract on body fat
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of intake of Kaempferia parviflora extract for 12 weeks on body fat mass reduction in males and females with aged 20-64.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body fat mass (DEXA)
Key secondary outcomes
lean mass/body fat percentage/bone mineral density(DEXA), waist circumference, hip circumference, W/H ratio, body weight, BMI, soft Lean mass/body fat mass/body fat percentage/segmental lean mass/extracellular water ratio/basal metabolic expenditure(Impedance method), total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, glucose, HbA1c
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 of test food for 12 weeks
Interventions/Control_2
Intake of placebo food 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese Males and females aged of 20-64 years
2. Subjects with BMI 25-29.9 kg/m2
3. Subjects who can visit on schedule days
4. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1. Subjects who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs
2. Subjects who are under treatment or have a history of dyslipidemia, high blood pressure, or diabetes
3. Subjects who are under treatment that may affect weight
4. Subjects who have significant weight change within 3 months of the start of the study
5. Subjects who participated in weight loss programs, etc. within 3 months of the start of the study
6. Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study
7. Subjects who underwent surgery due to illness or injury within 6 months of the start of the study, and subjects who underwent obesity surgery within 1 year
8. Subjects who regularly use health foods and supplements affecting the study
9. Possible pregnancy, pregnancy, and lactation
10. Heavy drinkers
11. Subjects who feel bad mood by blood collect
12. Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period
13. Subjects who have some metal inside the body
14. Shift worker
15. Subjects who plan business trip or trip for 10 days or more a month
16. Subjects who have allergy related to the test foods
17. Subjects who have thyroid stimulating hormone of 10 mIU/L or more, creatinine of 1.5 mg/dL or more, and AST or ALT of more than 3 times the upper limit of clinical laboratory standard value.
18. Subjects already participating in other clinical trials
19. Subjects who are ineligible due to physician's judgment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
061-1351
Address
3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Yuhki |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido
TEL
0123-34-0412
Homepage URL
t-yuhki@ndrcenter.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2 jo, Toyohira, Sapporo, Hokkaido
Tel
011-836-3531
s-fukui@jikokai.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 | 06 | 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
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 19 | 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 | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054742
