UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057592 |
|---|---|
| Receipt number | R000065640 |
| Scientific Title | Research on the sensitivity of metabolic hormones to sugar intake in young adults-the effects of body size and lifestyle habits |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/04/11 18:00:54 |
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Basic information
Public title
Research on metabolic hormone changes following glucose intake in young adults
Acronym
Research on metabolic hormone changes following glucose intake in young adults
Scientific Title
Research on the sensitivity of metabolic hormones to sugar intake in young adults-the effects of body size and lifestyle habits
Scientific Title:Acronym
Research on the sensitivity of metabolic hormones to sugar intake in young adults-the effects of body size and lifestyle habits
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the blood kinetics of metabolic hormones after sugar intake in young healthy adults
Basic objectives2
Others
Basic objectives -Others
Elucidation of the hormone kinetics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood sampling data: Blood hormone concentrations after glucose loading; Body composition analysis data: Weight, BMI, body fat mass, body fat percentage, muscle mass; Questionnaire survey data: Eating behaviors in daily life
Key secondary outcomes
Questionnaire survey data: Diet, exercise, and sleep habits
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sugar load test, Non-sugar load test
Interventions/Control_2
Non-sugar load test, Sugar load test
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy, volunteers
Key exclusion criteria
Volunteers with a current or past history of diabetes, dyslipidemia, or other serious illnesses; Those taking medications for any illness; Those on special dietary restrictions; Current smokers; Those who are not suitable for measurement using a body composition analyzer
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka Metropolitan University Graduate Schoool of Medicine
Division name
Sports Medicine
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
tkhr6719@omu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka Metropolitan University Graduate Schoool of Medicine
Division name
Sports Medicine
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
Homepage URL
https://www.omu.ac.jp/med/sportsmed/
tkhr6719@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Medical Research Ethics Committee
Address
6th floor, Abeno Medix, 1-2-7 Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.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 | 07 | Month | 30 | 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 | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065640
