UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062311 |
|---|---|
| Receipt number | R000071300 |
| Scientific Title | Effects of intake of the test food on energy intake: A randomized, double-blind, placebo-controlled, parallel-group comparison study |
| Date of disclosure of the study information | 2026/07/24 |
| Last modified on | 2026/07/23 10:26:30 |
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Basic information
Public title
Effects of intake of the test food on energy intake
Acronym
Effects of intake of the test food on energy intake
Scientific Title
Effects of intake of the test food on energy intake: A randomized, double-blind, placebo-controlled, parallel-group comparison study
Scientific Title:Acronym
Effects of intake of the test food on energy intake: A randomized, double-blind, placebo-controlled, parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of 12-week continuous intake of the test food on reducing calorie intake in Japanese adults with a BMI from 25 kg/m2 to less than 30 kg/m2.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total energy intake (food intake)
Key secondary outcomes
Body weight, BMI, GLP-1 (active and total: fasting and postprandial), VAS questionnaire for satiety, questionnaire for appetite, body fat percentage, fat mass, fat-free mass, muscle mass, total body water, body water percentage, basal metabolic rate, visceral fat area, fasting blood glucose, fasting lipids (TC, LDL-C, HDL-C, TG), fasting leptin
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
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test food (tablet form, 4 tablets per day, 2 tablets in the morning and 2 tablets in the evening) for 12 weeks.
Interventions/Control_2
Continuous intake of placebo food (tablet form, 4 tablets per day, 2 tablets in the morning and 2 tablets in the evening) 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Aged 20 to 69 years at the time of informed consent.
(2) Japanese males and females.
(3) Body mass index from 25 to less than 30 kg per square meter.
(4) Individuals who have received a full explanation of the purpose and details of the study, have the capacity to give consent, can fully understand the content, and can provide their own consent via electronic informed consent.
Key exclusion criteria
(1) Individuals receiving or planning to receive medical counseling, treatment, or medication (including private practice prescription) for weight or fat loss.
(2) Individuals with chronic diseases (diabetes, dyslipidemia, hypertension, anemia, perennial allergy, asthma, etc.) receiving treatment/medication.
(3) History of serious cerebrovascular, heart, liver, kidney, blood, or endocrine disease.
(4) History of serious GI surgery (except appendectomy).
(5) Weight fluctuation of 3 kg or more within the past 3 months.
(6) Risk of allergy to test foods (yeast) or load meals.
(7) Significant abnormalities in screening tests.
(8) History of feeling unwell during blood sampling.
(9) Blood donation history (200 mL within 4 weeks, component within 2 weeks for both; 400 mL within 16 weeks for females, 12 weeks for males).
(10) Barium test planned within 2 weeks before or during visits.
(11) Intrabdominal or body metal/medical devices (pacemakers, etc.).
(12) Unable to stop health foods/supplements.
(13) Current smokers.
(14) Heavy alcohol users (around 60 g or more alcohol per day).
(15) Irregular sleep/diet habits (shift/night work).
(16) Expected major changes in lifestyle, diet, or exercise.
(17) Lactating, pregnant, or planning pregnancy.
(18) Current, recent (within 4 weeks), or planned participation in other trials.
(19) Otherwise judged ineligible by the investigator.
Target sample size
48
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 | Anna |
| Middle name | |
| Last name | Kadodani |
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
DHC Corporation
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 Joto-machi, Maebashi-shi, Gumma
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 24 | 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 | 16 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 14 | 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 | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071300
