UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057907 |
|---|---|
| Receipt number | R000065854 |
| Scientific Title | Examination of the effect of body fat reduction by consumption of test foods |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/07/07 09:56:18 |
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Basic information
Public title
Examination of the effect of body fat reduction by consumption of test foods
Acronym
Examination of the effect of body fat reduction by consumption of test foods
Scientific Title
Examination of the effect of body fat reduction by consumption of test foods
Scientific Title:Acronym
Examination of the effect of body fat reduction by consumption of test foods
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of 12 weeks of consumption of the test food on body fat reduction and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body Fat Assessment Index
(Week 0, Week 12)
Key secondary outcomes
* Secondary indexes
1) Indicators related to body fat assessment (1)
2) Body composition measurement (2)
3) Weighing at home (3)
4) Waist circumference and buttock circumference measurements/waist-to-hip ratio (2)
5) brief-type self-administered diet history questionnaire (2)
* Safety
1) Blood pressure, pulsation (2)
2) Hematologic test (2)
3) Blood biochemical test (2)
4) Urine analysis (2)
5) Doctor's questions (2)
6) Side effects/ Adverse events(4)
7) Subject's diary(3)
(1): Week 0, Week 12
(2): Week 0, Week 6, Week 12
(3): Daily from the start of the study food intake to the end of the study
(4): Week 6, Week 12
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food A (2 tablets in a day; 12 weeks).
Interventions/Control_2
Oral intake of the test food B (2 tablets in a day; 12 weeks).
Interventions/Control_3
Oral intake of the placebo food (2 tablets in a day; 12 weeks).
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) Men and women between 20 and 64 years of age at the time of obtaining consent to participate in the study.
2) Individuals whose BMI is not less than 23.0 kg/m2 and under 30.0 kg/m2.
3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
4) Individuals who can come to the designated venue for this study and be inspected.
Key exclusion criteria
Individuals
1) using medical products.
2) who used a drug to treat a disease in the past 1 month.
3) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
4) with co-morbidities and serious history of gastrointestinal conditions.
5) with a history or current history of mental illness, sleep disorders, diabetes, hypertension, dyslipidemia or serious illness.
6) who have metal objects in their bodies that cannot be removed, individuals with cardiac pacemakers.
7) who have had a significant change in body weight within 3 months of the start of the study.
8) who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
9) who may develop allergic symptoms to the tested food, or to any other food or drug.
10) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
11) with possible changes of life style during the test period.
12) who are currently, and within the past 3 months have been, or will be during the study period, taking health food products containing ingredients similar to those in the test food.
13) who are currently, or have been within the past 3 months, habitual consumers of foods for specified health uses, foods with functional claims, and health foods that claim to reduce body fat, and who plan to consume such foods during the study period.
14) who are or are possibly pregnant, or are lactating.
15) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
16) judged inappropriate for the study by the principal.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Hiroe |
| Middle name | |
| Last name | Maruyama |
Organization
API CO., Ltd.
Division name
Product Development Department, R&D Division
Zip code
500-8558
Address
1-1, Kano Sakuradacho, Gifu Shi, Gifu, 500-8468, Japan
TEL
058-271-3838
maruyama-hiroe@api3838.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
API 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2025 | Year | 05 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065854
