UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052822 |
|---|---|
| Receipt number | R000060286 |
| Scientific Title | A placebo-controlled, double-blind, randomized, comparative trial concerning body composition effected by continuously taking test food in healthy adults with mildly obese. |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2024/05/21 14:21:23 |
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Basic information
Public title
A placebo-controlled, double-blind, randomized, comparative trial concerning body composition effected by continuously taking test food in healthy adults with mildly obese.
Acronym
A placebo-controlled, double-blind, randomized, comparative trial concerning body composition effected by continuously taking test food in healthy adults with mildly obese.
Scientific Title
A placebo-controlled, double-blind, randomized, comparative trial concerning body composition effected by continuously taking test food in healthy adults with mildly obese.
Scientific Title:Acronym
A placebo-controlled, double-blind, randomized, comparative trial concerning body composition effected by continuously taking test food in healthy adults with mildly obese.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of taking test food for 12 weeks on body composition in healthy male and female whose BMI is between 25.0 and less than 30.0kg/m2 and aged between 20 and less than 60.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-12-week changes in total body fat amount measured by DXA
-12-week changes in body fat percentage measured by DXA
Key secondary outcomes
-12-week changes in Lean body mass
-12-week changes in body weight
-12-week changes in BMI
-12-week changes in waist circumference, hip circumference, and ratio waist circumference to hip circumference
-12-week changes in fat mass, fat percentage, and lean body mass in each region measured by DXA
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
Take a capsule of the test food every morning after breakfast with cold or warm water.
Interventions/Control_2
Take a capsule of the placebo food every morning after breakfast with cold or warm water.
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. Age: 20 to less than 60 years old
2. Gender: Japanese Male and female Japanese
3. BMI is between 25.0 and less than 30.0 kg/m2
4. Can write an electronic daily log using smartphones or PCs
5. Received an adequate explanation of the purpose of the study and voluntarily participated in the study under informed consent
Key exclusion criteria
1. Have serious illnesses, or a history of malignant tumor in 6 months or serious illnesses.
2. Have took medicines, quasi-drug, foods or supplements affecting body weight and body fat, or treatment of obesity in one month.
3. Have had bariatric surgery in the past year or are planning to undergo surgery within 6 months after obtaining informed consent.
4. Are obese or overweight due to endocrine diseases, or under treatment or medication for gastrointestinal diseases, or have those history.
5. Have a psychologically serious medical history or illness, or a history of alcohol or other drug abuse.
6. Are judged to be unable to exercise due to skeletal muscle disease.
7. Have lost 3 kg or more of their body weight within the past 3 months.
8. Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable.
9. Receive diet or exercise therapy under medical supervision.
10. Have been taking quasi-drugs, foods, or supplements that affect the outcome of the study. Who can discontinue intake during the study is acceptable.
11. Have allergies to drugs or foods.
12. Shift workers.
13. Plans to extremely change lifestyle during the study.
14. Alcohol drinkers, over an average of 40 g/day.
15. Plans to travel abroad during the study period.
16. Are currently pregnant or breastfeeding, or planning to become pregnant during the study.
17. Have above 200 mL blood donation within one month, or above 400 mL blood donation within 3 months before this study.
18. Had joined other clinical trials from one month before the trial, have currently been joined other clinical trials, or plans to join other clinical trials during the study.
19. Are obsessed with orthopedic metal devices.
20. Are unsuitable for the study, judged by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Higashikoganei-sakura clinic
Division name
Head doctor
Zip code
184-0011
Address
4-37-26 Higashicho Koganei-shi Tokyo Japan
TEL
03-6704-5968
clinical-trial@imeqrd.co.jp
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
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
Nutrione Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Nutrione 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
| 2023 | Year | 12 | Month | 06 | 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
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060286
