UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055996 |
|---|---|
| Receipt number | R000063988 |
| Scientific Title | A study evaluating the body fat reduction effects of the test food |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2026/01/27 13:57:16 |
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Basic information
Public title
A study evaluating the body fat reduction effects of the test food
Acronym
A study evaluating the body fat reduction effects of the test food
Scientific Title
A study evaluating the body fat reduction effects of the test food
Scientific Title:Acronym
A study evaluating the body fat reduction effects of the test food
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effects of 12 weeks of test food consumption on body fat reduction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat (total fat area)
Key secondary outcomes
1)Visceral fat area
2)Subcutaneous fat area
3)Body weight
4)BMI
5)Body fat weight
6)Body fat percentage
7)Fat free mass
8)Waist circumference
9)Hip circumference
10)Waist/hip ratio
11)Segmental muscle mass (limbs and trunk)
12)Triglycerides
13)Total cholesterol
14)HDL-cholesterol
15)LDL-cholesterol
16)Fasting blood glucose
17)Insulin
18)HbA1c
19)HOMA-IR
20)Comprehensive analysis of gut bacteria composition
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
Daily intake of the test food for 12 weeks
Interventions/Control_2
Daily intake of placebo (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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese males and females aged 20 or more and less than 60.
2)Those with a BMI of 23.0 kg/m^2 or more and less than 30.0 kg/m^2 at the time of screening.
3)Those with a visceral fat area of 80 cm^2 or more at the time of screening.
4)Those with a waist circumference of 85 cm or more for men and 90 cm or more for women at the time of screening.
5)Those with a body fat percentage of 25 % or more at the time of screening.
6)Those who fall under ratings A to C in the "Guidelines for assessing medical examination results and follow-up guidance for health checkups", 2024 edition published by the Japan Society of Ningen Dock.
7)Those who can visit the hospital on the designated visit dates.
8)Those who can take the test food once a day.
9)Those who can fill in lifestyle questionnaires every day during the test period.
10)Those who can complete a dietary survey for the set period.
11)Those who can finish eating and drinking by 9pm and refrain from taking alcohol the day before the tests.
12)Those who can comply with intake restrictions other than drinking an appropriate amount of water, until the end of the test on the day of the tests.
13)Those who can follow instructions from the hospital regarding CT scans.
14)Those who can submit the written informed consent form.
Key exclusion criteria
1)Those who are on treatment or have a history of malignant tumors, heart failure, or myocardial infarction.
2)Those with a pacemaker or implantable cardioverter defibrillator.
3)Those who are currently undergoing treatment for the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases.
4)Those who regularly use medicines, quasi-drugs, supplements, and diet foods that affect body fat.
5)Those who cannot refrain from consuming health foods that affect body fat.
6)Those who cannot refrain from consuming foods/ drinks containing lactic acid bacteria other than the test foods (yogurt, lactic acid drinks such as Yakult, etc.).
7)Those who regularly drink an amount of alcohol exceeding the recommended amount.
8)Those who smoke an average of more than 20 cigarettes per day.
9)Those with extremely irregular lifestyles (those who work night shifts or shift rotations).
10)Those who have large changes in their diet and exercise habits and are unable to maintain their daily lifestyle.
11)Those who underwent a barium examination 2 weeks prior to the CT scan.
12)Those with metal or other materials embedded in the area to be CT scanned.
13)Those whose weight change in the past year is outside the range of 1 to 2 kg.
14)Those who regularly exercise.
15)Those who have had blood drawn or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test.
16)Those who have a dairy allergy or who have hypersensitive reactions to the test foods.
17)Those who are pregnant, breastfeeding or planning to become pregnant during the study period.
18)Those who participated in other clinical trials within a month prior to the date of consent, or plan to participate in other clinical trials during the study period.
19)Those who are judged as ineligible for the study by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueno |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
049-242-8165
hiroshi-ueno@meg-snow.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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, Gokammachi, Maebashi-Shi, Gumma, 371-0813, 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
医療法人 前橋北病院／Maebashi North Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063988
