UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051801 |
|---|---|
| Receipt number | R000059116 |
| Scientific Title | Exploratory study of individual differences in the weight loss effect of dietary intervention on obese people [Trial No. g2023002] |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/02 20:58:21 |
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Basic information
Public title
Dietary Intervention Obesity Improvement Trial 2023
Acronym
Dietary Intervention Obesity Improvement Trial 2023
Scientific Title
Exploratory study of individual differences in the weight loss effect of dietary intervention on obese people [Trial No. g2023002]
Scientific Title:Acronym
Exploratory study of individual differences in the weight loss effect of dietary intervention on obese people [Trial No. g2023002]
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the relationship between the effects of dietary intervention on weight loss/ visceral fat reduction and other analysis items.
Basic objectives2
Others
Basic objectives -Others
Observation of dietary intervention effects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of the relationship between weight loss / visceral fat loss before and after the intervention and other measurement items (physical test, blood test, etc.)
Key secondary outcomes
Comprehensive relevance analysis of all measurement items.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Dietary guidance for weight loss and visceral fat reduction will be provided once every two weeks for two months.
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
Key inclusion criteria
1.Obese or lightly obese (Body Mass Index [BMI] >=25, If insufficient number of subjects, BMI >=23).
2.Person who has a diet intention.
3.Person who has a smartphone and can record meals and write a life diary using the app.
4.Person who agree to use the exercise and diet management app "Asken".
Key exclusion criteria
1. Person who has suffer from chronic diseases currently (diabetes, hypertension, hyperlipidemia, gout, kidney disease, rheumatism, respiratory disease, etc.) and are taking medication. (however, users of drugs that suppress allergic symptoms such as allergic rhinitis can be included in the subjects)
2. Person who has difficulty participating in research due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, or other diseases.
3. Person who with alcoholic drinkers. (alcohol equivalent 60g / day or more) : (Beer: 3 medium bottles (1.5L), Sake: 3 go (540ml), Whiskey: 3 double glasses (180ml), Shochu: 1.8go (330ml) or more)
4. Person who has a history of gastrointestinal resection (excluding cecal resection).
5. Person who has collected 200 mL of blood (donated blood, etc.) within 1 month or 400 mL or more within 3 months of the start of this study.
6. Person who has skin diseases (atopic dermatitis, acne vulgaris, psoriasis, etc.) on face.
7. Person who use medical external medicine on the face.
8. Person who has excessive sunburn on the face.
9. Person who has skin diseases, metal allergies, pacemakers, etc. in their bodies.
10. Person who plan to participate in other clinical trials during the trial participation period.
11. Person who are not day shifts such as night shifts and rotation shifts.
12. Person who has felt sick at the time of blood collection, or person who has difficulty in collecting blood because the blood vessels in the arm are difficult to see.
13. Person who has a history of drug dependence, alcohol dependence, or current medical history.
14. Person who has plan to travel or travel for more than 2 weeks during the test period.
15. Person who has deemed inappropriate to participate in this study by the principle investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Umeda |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
umeda.mai@kao.com
Sponsor or person
Institute
Macromill,Inc.
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 08 | Month | 10 | 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
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059116
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