UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062121 |
|---|---|
| Receipt number | R000071084 |
| Scientific Title | A Study on the Effects of Continuous Intake of the Test Food on Body Fat Reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 17:15:04 |
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Basic information
Public title
A Study on the Effects of Continuous Intake of the Test Food on Body Fat Reduction
Acronym
A Study on the Effects of Continuous Intake of the Test Food on Body Fat Reduction
Scientific Title
A Study on the Effects of Continuous Intake of the Test Food on Body Fat Reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Scientific Title:Acronym
A Study on the Effects of Continuous Intake of the Test Food on Body Fat Reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 12-week continuous intake of a test food on abdominal fat area (especially visceral fat area) through a randomized, double-blind, placebo-controlled, parallel-group comparison study in healthy Japanese adult men and women with a BMI of 25 kg/m^2 or more and less than 30 kg/m^2. In addition, low-dose and high-dose groups are established to evaluate dose-dependent effects and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Abdominal visceral fat area
Key secondary outcomes
1. Abdominal subcutaneous fat area
2. Abdominal total fat area
3. Waist circumference
4. Physical examination (body weight, body mass index [BMI], and body composition)
5. Lipid and energy metabolism-related markers
6. Adipocytokines and glucose metabolism markers
7. Inflammatory and oxidative stress markers
8. Fat accumulation and metabolism markers
9. Metabolomic analysis
10. Blood pressure (systolic blood pressure and diastolic blood pressure)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food 1 group (Low dose): Participants take 3 capsules containing a low dose of Sudachi peel extract powder once daily for 12 weeks.
Interventions/Control_2
Test food 2 group (High dose): Participants take 3 capsules containing a high dose of Sudachi peel extract powder once daily for 12 weeks.
Interventions/Control_3
Placebo group: Participants take 3 placebo capsules (indistinguishable in appearance and flavor, containing no Sudachi peel extract powder) once daily for 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.Individuals aged between 20 and 64 years at the time of obtaining informed consent.
2.Healthy Japanese men and women.
3.Individuals with a BMI of 25 kg/m^2 or more and less than 30 kg/m^2 at the time of screening
4.Individuals who have the capacity to consent, have received sufficient explanation regarding the purpose and content of the study, have fully understood the information, and voluntarily agreed to participate by providing written informed consent.
Key exclusion criteria
1.Current/planned weight-loss treatment, counseling, or medication (incl. self-pay care) by a physician.
2.Current/past 6-month use of drugs affecting weight, body/visceral fat, glucose/lipid metabolism (e.g., hypoglycemics, glucocorticoids, GLP-1 agonists, SGLT2 inhibitors, anti-obesity/antidiabetic drugs, dyslipidemia agents).
3.History of serious cerebrovascular, heart, liver, kidney, blood, or endocrine disease.
4.History of major gastrointestinal surgery (e.g., gastrectomy, resection; excl. appendectomy).
5.Weight change +/-3 kg within the past 3 months.
6.Risk of allergic reaction to the test food.
7.Significant abnormalities in vital signs, physical exams, or blood tests at screening.
8.History of feeling unwell or worsening condition due to blood sampling.
9.Potential difficulties ensuring safety in CT scanning or image analysis.
10.Planned gastric X-ray (barium meal) from 2 weeks before to the end of the examination.
11.Blood donation within screening: 200mL whole (4 weeks), component (2 weeks); 400mL whole (females: 16 weeks, males: 12 weeks).
12.Unable to stop FOSHU, Foods with Function Claims, or supplements affecting weight, fat, or glucose/lipid metabolism during the study.
13.Planned new diet, exercise, training, aesthetics, or medical procedures for weight/fat loss or muscle gain during the study.
14.Current smokers.
15.Habitual alcohol drinkers.
16.Extremely irregular sleep or dietary habits.
17.Likely significant changes in living environment, diet, or exercise during the study.
18.Lactating, pregnant, possibly pregnant, or planning pregnancy during the study.
19.Participation in other clinical studies currently, within 4 weeks prior to screening, or planned during the study.
20.Otherwise judged ineligible by the principal investigator.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
umin_info@macromillcarenet.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
DKS Co. Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of Tokyo Haneda Watanabe Clinic
Address
1-6-15 Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
wnb.cto@gmail.com
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
医療法人社団 糺榮会 東京羽田渡辺クリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 02 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071084
