UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062414 |
|---|---|
| Receipt number | R000071427 |
| Scientific Title | Evaluation of the Body Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with Dietary Improvement |
| Date of disclosure of the study information | 2026/08/02 |
| Last modified on | 2026/07/30 22:04:10 |
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Basic information
Public title
Evaluation of the Body Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with Dietary Improvement
Acronym
Evaluation of the Body Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with Dietary Improvement
Scientific Title
Evaluation of the Body Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with Dietary Improvement
Scientific Title:Acronym
Evaluation of the Body Fat-Reducing Effect of Continuous Consumption of the Test Food in Conjunction with Dietary Improvement
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the body fat-reducing effect of continued consumption of the test food in conjunction with dietary improvement in obese (Class I obesity) adult men and women aged 20 to 64 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in abdominal total fat area from baseline to Week 12.
Key secondary outcomes
Abdominal total fat area, abdominal visceral fat area, abdominal subcutaneous fat area, total muscle mass, regional muscle mass (right arm, left arm, trunk, right leg, and left leg), basal metabolic rate, body mass index (BMI), waist circumference, step count, and dietary records.
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 | Other |
Interventions/Control_1
Participants in the test food group will receive dietary improvement guidance and consume the test food for 12 weeks.
Interventions/Control_2
Participants in the control food group will receive dietary improvement guidance and consume the control 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) Male or female adults who are 20 years of age or older at the time of obtaining informed consent and younger than 65 years of age at the end of the intake period.
(2) Individuals with a BMI of >=25.0 kg/m2 and <30.0 kg/m2.
(3) Individuals who are able to visit the designated study site on the scheduled visit dates.
(4) Individuals who have been provided with a full explanation of the purpose and procedures of the study, have sufficiently understood them, and have provided written informed consent.
Key exclusion criteria
(1) Individuals whose fat energy ratio is <30% at screening.
(2) Individuals with systolic blood pressure <90 mmHg.
(3) Pregnant, potentially pregnant, or breastfeeding individuals.
(4) Individuals who donated blood components or 200 mL whole blood within 4 weeks before study initiation.
(5) Males who donated >=400 mL whole blood within 12 weeks before study initiation.
(6) Females who donated >=400 mL whole blood within 16 weeks before study initiation.
(7) Males whose total blood donation volume during the previous 12 months plus study-related blood collection would exceed 1,200 mL.
(8) Females whose total blood donation volume during the previous 12 months plus study-related blood collection would exceed 800 mL.
(9) Individuals currently participating in, recently completing, or planning to participate in another clinical study.
(10) Individuals with irregular lifestyles, including shift workers.
(11) Individuals with excessive alcohol consumption.
(12) Individuals smoking >=21 cigarettes/day.
(13) Individuals unable to consume the study foods as instructed.
(14) Individuals unable to record dietary intake using the designated mobile application.
(15) Regular users of FOSHU, FFC, supplements, or other health foods that may affect study outcomes.
(16) Individuals regularly taking medications that may affect study outcomes.
(17) Individuals expecting major lifestyle changes during the study.
(18) Individuals with:
a) Cardiac, hepatic, or renal disease.
b) Respiratory disease.
c) A history of cardiovascular disease.
d) Diabetes mellitus.
e) Allergies to the study foods.
(19) Individuals judged ineligible by the Principal Investigator or Sub-Investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Maekawa |
Organization
Suntory beverage & Food Co., Ltd.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1804-0276
Toshihiro_Maekawa@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Shiga |
Organization
Suntory beverage & Food Co., Ltd.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-7443
Homepage URL
Kazuto_Shiga@suntory.co.jp
Sponsor or person
Institute
Apo Plus Station Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Ushikubo-machi, Maebashi-shi, Gunma 371-0816, Japan
Tel
027-212-5608
sagawa@mc-connect.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
前橋北病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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 | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 27 | 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 | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071427
