UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052947 |
|---|---|
| Receipt number | R000060403 |
| Scientific Title | Effects of Kaempferia parviflora extract and essential amino acids on basal metabolism of the elderly -Randomized, double-blind, placebo-controlled parallel group study- |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/06/12 11:39:29 |
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Basic information
Public title
Effects of Kaempferia parviflora extract and essential amino acids on basal metabolism of the elderly -Randomized, double-blind, placebo-controlled parallel group study-
Acronym
Effects of Kaempferia parviflora extract and essential amino acids on basal metabolism of the elderly
Scientific Title
Effects of Kaempferia parviflora extract and essential amino acids on basal metabolism of the elderly -Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym
Effects of Kaempferia parviflora extract and essential amino acids on basal metabolism of the elderly
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of intake of test food for 1 years on basal metabolism in males and females with over 50 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basal metabolism
Key secondary outcomes
Body composition
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 1 years
Interventions/Control_2
Intake of placebo food for 1 years
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Males and females with over 50 years
2. Subjects who recognize the object and contents of the study and submit the written informed consent
3. Subjects who can visit on schedule days
4. Subjects who are eligible due to physician's judgment
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 received medication treatment due to serious illness (diabetes, dyslipidemia, et al)
3. Subjects who underwent surgery due to illness or injury within 3 months of the start of the study
4. Subjects who have allergy related to the test foods
5. Heavy drinkers
6. Subjects already participating in other clinical trials
7. Subjects who are ineligible due to physician's judgment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Fukushima |
Organization
Fukushima orthopedic hospital
Division name
Director
Zip code
325-0044
Address
1-10 Yayoi, Nasushiobara, Tochigi Japan
TEL
0287-62-0805
m.fukushima@f-o-h.net
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Yoshino |
Organization
Maruzen Pharmaceuticals Co., Ltd.
Division name
Research Center
Zip code
729-3102
Address
1089-8 Sagata, Shinichi, Fukuyama, Hiroshima, Japan
TEL
0847-52-5501
Homepage URL
s-yoshino@maruzenpcy.co.jp
Sponsor or person
Institute
Fukushima orthopedic hospital
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
The Ethics Committee of Fukushima Orthopedic Hospital
Address
1-10 Yayoi, Nasushiobara, Tochigi Japan
Tel
0287-62-0805
s.fukushima@f-o-h.net
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
| 2025 | Year | 03 | Month | 31 | 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 | 07 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060403
