UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058404 |
|---|---|
| Receipt number | R000066641 |
| Scientific Title | A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity: A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Comparison Trial |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/09 19:11:53 |
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Basic information
Public title
A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity: A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Comparison Trial
Acronym
A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity
Scientific Title
A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity: A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Comparison Trial
Scientific Title:Acronym
A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 12 weeks of continuous consumption of a test supplement on body composition in men and women aged 20 to under 60 years with a BMI between 25.0 kg/m^2 and 30.0 kg/m^2.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body fat mass over 12 weeks, measured using the DXA method.
Key secondary outcomes
- Change in lean body mass (LBM) over 12 weeks.
- Change in body weight and BMI over 12 weeks.
- Change in waist circumference over 12 weeks.
- Changes in fat mass, fat percentage, and lean body mass in specific regions (arms, legs, trunk, abdomen [Android], and hips [Gynoid]) over 12 weeks, measured using the DXA method.
- Changes in blood markers (leptin, adiponectin, T-cho, HDL-C, LDL-C, TG) over 12 weeks.
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
Placebo group: 10 capsules taken once daily with water or lukewarm water after breakfast.
Interventions/Control_2
Test supplement group: 10 capsules taken once daily with water or lukewarm water after breakfast.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 to under 60 years.
2. Gender: Japanese men and women.
3. BMI: Between 25.0 kg/m^2 and 30.0 kg/m^2.
4. Ability to input electronic diaries via smartphone or PC.
5. Individuals who have received a sufficient explanation about the study's objectives and content, fully understand them, voluntarily wish to participate and provide written consent for participation.
Key exclusion criteria
1. Currently undergoing treatment for any disease with medication or herbal remedies (occasional use permitted).
2. Individuals under dietary or exercise therapy supervised by a physician.
3. Individuals with a history or current presence of severe diseases.
4. Individuals with gastrointestinal disorders or a history of gastrointestinal surgery affecting digestion and absorption (appendicitis excluded).
5. Individuals who have undergone obesity surgery within the past year or are scheduled for such surgery.
6. Individuals consuming healthy foods or supplements that may affect obesity, blood sugar, or lipid metabolism (including foods with specific health claims or functional labeling; participation allowed if discontinued after consent).
7. History or presence of drug or food allergies.
8. Individuals with irregular lifestyles due to night shifts or rotating work schedules.
9. Individuals planning significant lifestyle changes (diet, sleep, exercise, etc.) during the study period.
10. Heavy alcohol consumers.
11. Individuals planning overseas travel during the study period.
12. Pregnant, breastfeeding, or planning to become pregnant during the study period.
13. Individuals who have undergone blood collection exceeding 200 mL within the past month or 400 mL within the past three months.
14. Individuals who participated in other clinical studies within the past month or are currently participating/planning to participate during the study period.
15. Individuals with implanted orthopedic metal devices.
16. Individuals considered unsuitable for participation by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Medical corporation Hirookai HigashiKoganei Sakura Clinic
Division name
Hospital director
Zip code
184-0011
Address
4-37-26 Higashicho, Koganei-shi, Tokyo
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
JY Globalfoods 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
0367045968
jimukyoku@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
| 2025 | Year | 07 | Month | 09 | 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
| 2025 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 09 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066641
