UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061416 |
|---|---|
| Receipt number | R000070270 |
| Scientific Title | A study on the Effects of Continued Consumption of the Test Food on Body Composition - Single Arm Open Label Trial - |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/01 15:53:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the Effects of Continued Consumption of the Test Food on Body Composition
Acronym
A study on the Effects of Continued Consumption of the Test Food on Body Composition
Scientific Title
A study on the Effects of Continued Consumption of the Test Food on Body Composition
- Single Arm Open Label Trial -
Scientific Title:Acronym
A study on the Effects of Continued Consumption of the Test Food on Body Composition
- Single Arm Open Label Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 8 weeks of continuous consumption of the test food on body composition in women aged 30 to under 60 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical examination: weight, BMI, waist circumference, body fat percentage
Key secondary outcomes
-Blood tests: blood lipids (triglycerides, HDL-C, LDL-C),liver function(AST, ALT, gamma-GPT, cholinesterase),change in blood glucose
-CT scans: abdominal fat area (visceral fat area, subcutaneous fat area, total fat area)
-Additional blood tests (hematology, biochemistry)
-Physiological tests (blood pressure, pulse)
-Incidence of adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
3 units of the test food are extracted in at least 1050 ml of water, refrigerated for 2 hours, and consumed before or with meals and snacks. The entire amount daily for 8 weeks
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Japanese females with aged 30 and 60 years at the time of informed consent
2.BMI >=25.0 kg/m^2
3.Body fat percentage >= 30%
4.Able to install a dietary survey app on their smartphone and record meals
5.Able to cooperate with full-body photography and consent to publication in academic presentations and media (including TV, magazines, internet, etc.). (Note: published images will show only from the neck down.)
6.Able to enter electronic diaries via smartphone or PC
7.Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent
Key exclusion criteria
1.Currently receiving outpatient treatment or medication (including Kampo) for any illness (as-needed use permitted)
2.Currently under dietary or exercise therapy supervised by a physician
3.Current or past history of serious illness
4.Habitually drink three or more cups of black tea per day (>=3 days/week; approx. 350 ml per cup)
5.Underwent or are planning weight loss procedures within the past year
6.Regularly use over-the-counter drugs, quasi-drugs, specified health foods, health foods, or supplements (participation allowed if discontinued after consent and during the study)
7.Current or past drug or food allergies
8.Excessive alcohol consumption (>=40g pure alcohol/day)
9.Excessive smoking (>=21 cigarettes/day)
10.Shift workers with night shifts
11.Planned overseas travel during the study
12.Presence of metal implants due to surgery
13.Use of cardiac pacemaker or other implanted medical devices
14.Claustrophobia
15.Poor health during blood collection
16.Pregnant, breastfeeding, or planning pregnancy during the study
17.Participation in another clinical study within 1 month prior to consent, currently participating, or plans to participate during the study
18.Deemed unsuitable for participation by the principal or sub-investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Shimada |
Organization
Wellness Research Institute
Division name
Wellness Research Institute
Zip code
151-0051
Address
Park Avenue, 1-20-1, Sendagaya, Shibuya-ku, Tokyo, 151-0051,Japan
TEL
080-5963-3937
y.shimada-s@wellness-lab.org
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
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Integrate 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
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
| 2026 | Year | 05 | Month | 11 | 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 | 04 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 06 | 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 | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070270
