UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048462 |
|---|---|
| Receipt number | R000055232 |
| Scientific Title | Exploratory study of individual differences in the weight loss effect of exercise intervention on obese people [Trial No. g2022005] |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2022/07/26 14:05:39 |
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Basic information
Public title
Exploratory study of individual differences in the weight loss effect of exercise intervention on obese people [Trial No. g2022005]
Acronym
Exploratory study of individual differences in the weight loss effect of exercise intervention on obese people [Trial No. g2022005]
Scientific Title
Exploratory study of individual differences in the weight loss effect of exercise intervention on obese people [Trial No. g2022005]
Scientific Title:Acronym
Exploratory study of individual differences in the weight loss effect of exercise intervention on obese people [Trial No. g2022005]
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the relationship between the effects of exercise intervention on weight loss/ visceral fat reduction and other analysis items.
Basic objectives2
Others
Basic objectives -Others
Investigation of the relationship between the effects of exercise intervention on weight loss/ visceral fat reduction and other analysis items.
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
Exercise guidance for weight loss and visceral fat reduction will be provided once every two weeks for two months. After that, a follow-up period will be set for one month.
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) Subjects who have a diet intention.
(3) Subjects who have a smartphone and can record meals and write a life diary using the app.
Key exclusion criteria
(1) Subjects currently receiving drug treatment due to some chronic disease.
(2) Subjects who have a history or current history of diseases such as liver disease, renal disease, respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, mental disease, cancer, infectious disease, and arrhythmia.
(3) Alcoholic drinkers.
(4) Subjects with a history of gastrointestinal resection.
(5) Subjects who collected 200 mL of blood within 1 month or 400 mL or more within 3 months of the start of this study.
(6) Subjects who have skin diseases (atopic dermatitis, acne vulgaris, psoriasis, etc.) on face.
(7) Subjects who use medical external medicine on the face.
(8) Subjects who have excessive sunburn on the face.
(9) Subjects who have skin diseases, metal allergies, pacemakers, etc. in their bodies.
(10) Subjects who plan to participate in other clinical trials during the trial participation period.
(11) Subjects who are not day shifts such as night shifts and rotation shifts
(12) Subjects who have felt sick at the time of blood collection, or those who have difficulty in collecting blood because the blood vessels in the arm are difficult to see.
(13) Subjects who have a history of drug dependence, alcohol dependence, or current medical history.
(14) During the two weeks prior to the visit to the test site, the patient or his / her family members had mild wind symptoms such as fever, cough, and sore throat, high fever, dyspnea, and strong fatigue. Those who have or are currently having dysgeusia or olfactory dysfunction.
(15) Subjects who plan to travel or travel for more than 2 weeks during the test period.
(16) Subjects with low physical fitness who cannot exercise moderately, or subjects who have orthopedic area disease or orthopedic area chronic disease.
(17) Subjects deemed inappropriate to participate in this study by the principal 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 laboratories
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 | Takahihro |
| Middle name | |
| Last name | Hasumura |
Organization
Kao Corporation
Division name
Biological Science Research laboratories
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
hasumura.takahiro@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
+81-3-5630-7263
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
花王株式会社 (東京)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 26 | 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
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055232
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