UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053658 |
|---|---|
| Receipt number | R000061239 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the peptide on reducing body fat |
| Date of disclosure of the study information | 2024/02/25 |
| Last modified on | 2024/02/20 12:26:10 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the peptide on reducing body fat
Acronym
Clinical study to evaluate the efficacy of the peptide on reducing body fat
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the peptide on reducing body fat
Scientific Title:Acronym
Clinical study to evaluate the efficacy of the peptide on reducing body fat
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the peptide on body fat in healthy adults with high BMIs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat
Key secondary outcomes
Body weight, BMI, Waist circumference
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
Oral ingestion of the test food for 12 weeks
Interventions/Control_2
Oral ingestion of the 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged more than 20 years, less than 65 years
2) Subjects with a BMI between 23 and 30
Key exclusion criteria
1) Subjects who have serious disease or who have history of serious disease
2) Subjects who regularly undertake medications that affect obesity, hyperlipidemia or lipid metabolism
3) Subjects who cannot stop taking health foods or supplements that affect obesity, hyperlipidemia or lipid metabolism
4) Heavy smokers (more than 21 cigarettes/day)
5) Subjects who have excessive alcoholic drinks (more than 60 g/day of alcohol)
6) Subjects with serious medication allergy or food allergy
7) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
8) Subjects who are currently participating, or intend to participate during this study period, in other trials involving the testing of other foods or the use of drugs or the application of cosmetics and drugs
9) Subjects who are considered to be inappropriate for this study by the principal investigator or the examination doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisao |
| Middle name | |
| Last name | Nakatani |
Organization
Yamaguchi Health Lab
Division name
General manager
Zip code
754-0041
Address
MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref
TEL
083-976-4095
info@yamaguchi-hl.com
Public contact
Name of contact person
| 1st name | Hisao |
| Middle name | |
| Last name | Nakatani |
Organization
Yamaguchi Health Lab
Division name
General manager
Zip code
754-0041
Address
MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref
TEL
083-976-4095
Homepage URL
info@yamaguchi-hl.com
Sponsor or person
Institute
Yamaguchi Health Lab
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.co.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
| 2024 | Year | 02 | Month | 25 | 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
| 2024 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
