UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053920 |
|---|---|
| Receipt number | R000061485 |
| Scientific Title | A study on the effect of continuous intake of test food on body composition in mildly obese adults - A randomized, placebo-controlled, double-blind, fixed-dose, parallel-group comparative trial - |
| Date of disclosure of the study information | 2024/03/23 |
| Last modified on | 2024/10/09 14:51:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effect of continuous intake of test food on body composition in mildly obese adults - A randomized, placebo-controlled, double-blind, fixed-dose, parallel-group comparative trial -
Acronym
A study on the effect of continuous intake of test food on body composition in mildly obese adults
Scientific Title
A study on the effect of continuous intake of test food on body composition in mildly obese adults - A randomized, placebo-controlled, double-blind, fixed-dose, parallel-group comparative trial -
Scientific Title:Acronym
A study on the effect of continuous intake of test food on body composition in mildly obese adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect of 12 weeks intake of test food on body composition in male and female with mildly obese.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, BMI, Body fat percentage
Key secondary outcomes
Abdominal fat area (Visceral fat area, Subcutaneous fat area, Total fat area), Waist circumference, Plasma acetate, Mood questionnaire
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food A with water or lukewarm water, 1 tablet at a time, once a day after dinner, for 12 weeks.
Interventions/Control_2
Intake of test food B with water or lukewarm water, 1 tablet at a time, once a day after dinner, for 12 weeks.
Interventions/Control_3
Intake of the placebo food with water or lukewarm water, 1 tablet at a time, once a day after dinner, for 12 weeks.
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. Age: 20 or more, and under 65
2. Mele or female
3. BMI 23.0kg/m^2 or more, and under 30.0kg/m^2
4. Subjects who can use smartphones or PC to record a digital diary
5. Subjects who received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent
Key exclusion criteria
Subjects --
1. currently receiving medical treatment with any drugs, except required single-use
2. receiving a diet therapy or physiotherapy under medical supervision
3. continuously taking quasi-medicine, food for specified health uses (FOSHU), foods with functional claim, or nutritional supplements / foods that affect obesity, hyperlipidemia, lipid metabolism, or hypertension, in three months before informed consent.
4. daily (4 or more times a week) taking quasi-medicine, FOSHUs, foods with functional claim, nutritional supplements / foods other than criteria 3.
5. regularly (4 or more times a week) taking foods rich in lactic acid bacteria
6. who have received weight loss treatment or have attended a beauty salon or gym within 1 year before informed consent
7. disable to stop drinking liquor on the day before the inspection date
8. who currently have or have a history of severe diseases
9. who had a gastrointestinal operation (except appendicitis)
10. who currently have or have a history of food/drug allergies
11. who currently have or have a history of alcoholism or drug addiction
12. who have metal parts inserted into their bodies due to surgery
13. using cardiac pacemaker or with implantable devices in their bodies
14. who have claustrophobia
15. taking alcohol more than 40 g/day
16. with excessive daily smoking: 20 or more cigarettes a day
17. working night shift
18. having plans of major change on their lifestyle(e.g., diet, sleep, and exercise) during the study period
19. planning to travel abroad during the study period
20. currently pregnant, breast-feeding or planning to get pregnant during the study period
21. who received positive test result after infectious disease testing at a start of the trial
22. who have participated another clinical study or have ingested test foods for other trials within 1 month.
23. judged by the physician to be unsuitable for this study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Tokumura |
Organization
Kabaya Foods Corporation
Division name
Marketing Headquarters, Research and Development Division
Zip code
709-2196
Address
1100 Mitsunonokuchi, Kita-ku, Okayama-shi, Okayama 709-2196, Japan
TEL
086-724-4830
kouki_tokumura@kabaya.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
Daiwa Ginza bldg. 3F, 6-2-1 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kabaya Foods 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
Suda Clinic institutional review board
Address
2-8-14 Takadanobaba, Shinjuku-ku, 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
| 2024 | Year | 03 | Month | 23 | 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 | 02 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 04 | 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 | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061485
