UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059389 |
|---|---|
| Receipt number | R000067930 |
| Scientific Title | The effect of a health program incorporating supplemental intake for body composition enhancement on weight loss outcomes |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/14 13:43:55 |
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Basic information
Public title
The effect of a health program incorporating supplemental intake for body composition enhancement on weight loss outcomes
Acronym
The effect of a health program incorporating supplemental intake for body composition enhancement on weight loss outcomes
Scientific Title
The effect of a health program incorporating supplemental intake for body composition enhancement on weight loss outcomes
Scientific Title:Acronym
The effect of a health program incorporating supplemental intake for body composition enhancement on weight loss outcomes
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratively evaluate the slimming effects of a health program incorporating supplemental intake for body composition enhancement, conducted for four weeks in adult men and women aged 20 to 59 with a slightly high BMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BMI(Body Mass Index)
Key secondary outcomes
Body weight, body fat percentage, body fat mass (by body part), skeletal muscle mass, lean body mass (by body part), free fat mass
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 | Behavior,custom |
Interventions/Control_1
In this study, participants will participate in the following health program daily for four weeks.
<Program Details>
Meal 1: Take one packet of the test food (XS Burn Fit Powder) daily before exercise.
Meal 2: Limit daily calorie intake to 1,800 kcal for men and 1,400 kcal for women.
Exercise: Approximately 10 minutes of designated exercise (XS Fitness) and at least 8,000 steps of walking.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Persons who have been fully informed of the purpose and content of this research, have the capacity to consent, fully understand, and freely and voluntarily volunteer to participate in this research, and agree to participate in the study
2.Persons who are Japanese adults, male and female, aged 20 or older and under 60 at the time of consent, and whose BMI is classified as slightly high
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who have a BMI of 30 or higher
3.Persons who have exercised regularly within the last year (e.g., jogging, gym training, sports, etc.)
4.Persons who are allergic to the test food
5.Persons who have a fructose metabolism disorder
6.Persons who usually take a large amount of test food
7.Persons who usually take medicine, specified health food, healthy food and supplements that may have effect to lipid metabolism
8.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
9.Persons who are judged to be ineligible by the supervising doctor or the principal investigator
10.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
03-6809-2722
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
rinsho@hc-sys.jp
Public contact
Name of contact person
| 1st name | Yukina |
| Middle name | |
| Last name | Fukuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
rinsho@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Amway Japan G.K.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 10 | Month | 14 | 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 | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067930
