UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052045 |
|---|---|
| Receipt number | R000059407 |
| Scientific Title | Functional evaluation of a novel functional cooked food machine using Peruvian functional food maca Lepidium meyenii WALP for obesity prevention |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2025/03/31 21:03:13 |
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Basic information
Public title
Functional evaluation of a novel functional cooked food machine using Peruvian functional food maca for obesity prevention.
Acronym
Functional evaluation of a novel functional cooked food machine using Peruvian functional food maca for obesity prevention.
Scientific Title
Functional evaluation of a novel functional cooked food machine using Peruvian functional food maca Lepidium meyenii WALP for obesity prevention
Scientific Title:Acronym
Functional evaluation of a novel functional cooked food machine using Peruvian functional food maca Lepidium meyenii WALP for obesity prevention
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of cooked foods containing maca on body fat reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body composition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Maca-containing cooked food intake group
Interventions/Control_2
Maca-free cooked food intake group
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those with no abnormalities in blood, blood pressure, or urine tests during the physical examination.
Key exclusion criteria
Those who take maca powder on a daily basis.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | T. |
| Last name | Asai |
Organization
Kyoto University
Division name
Division of Applied Biosciences
Zip code
606-8502
Address
kyoto city
TEL
075-753-6400
asai.tomoko.6k@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Asai |
Organization
Kyoto University
Division name
Faculty of Human Life and Environment
Zip code
630 8506
Address
Kitauoyahigashimachi, Nara
TEL
0742203453
Homepage URL
asai.tomoko.6k@kyoto-u.ac.jp
Sponsor or person
Institute
Nara Women's University
Institute
Department
Personal name
Funding Source
Organization
Nara Women's Unniversity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Women's Unniversity
Address
Kitauoyanishimachi, Nara-shi, Nara-ken, Japan
Tel
0742203453
asai.tomoko.6k@kyoto-u.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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059407
