UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046967 |
|---|---|
| Receipt number | R000053593 |
| Scientific Title | Changes in metabolic risks and gut microbiota during weight gain process of college athletes |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2024/08/29 15:02:43 |
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Basic information
Public title
Changes in metabolic risks and gut microbiota during weight gain process of college athletes
Acronym
Changes in metabolic risks and gut microbiota during weight gain process of college athletes
Scientific Title
Changes in metabolic risks and gut microbiota during weight gain process of college athletes
Scientific Title:Acronym
Changes in metabolic risks and gut microbiota during weight gain process of college athletes
Region
| Japan | Asia(except Japan) |
Condition
Condition
Not applicable to patients
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes in metabolic risks and intestinal environment during the weight gain process of college athletes who belong to the athletic club, where the body size directly affects athletic performance
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition, metabolic risks, gut microbiota
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
-Male college students who belong to the athletic club where the size of the physique affects the performance
-Male college students who do not have exercise habits
-Those who are not being treated for cardiovascular, respiratory, orthopedic diseases
-Those who have not taken antibiotics or antibacterial agents in the past 2 months
Key exclusion criteria
Those who do not meet the selection criteria
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | Ishiguro |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya-shi, Aichi
TEL
0527893948
tanaka-n@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | Ishiguro |
| Last name | Noriko |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya-shi, Aichi
TEL
0527893948
Homepage URL
tanaka-n@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the Research Center of Health, Physical Fitness and Sports
Address
Furo-cho, Chikusa-ku, Nagoya-shi, Aichi
Tel
0527893946
htc-rinri@adm.nagoya-u.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
| 2022 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053593
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
Results
Body weight, weight-adjusted thicknesses subcutaneous fat and abdominal cavity, and blood triglycerides in athletea group significantly increased after 6-month follow-up. The diversity of gut microbiota significantly decreased. No significant changes were observed in the control group. The change in body weight (%) in athletes significantly correlate with those of blood triglycerides (rs = 0.436) and Bacteroides (rs = -0.631).
Results date posted
| 2024 | Year | 08 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
1) The period of data collection was extended due to the job search of the student in charge of this project.
2) The graduation of the student in charge of this project.
Date of the first journal publication of results
Baseline Characteristics
1) Twenty-two college freshmen who were members of the American football or rugby team (athletes)
2) Ten healthy college freshmen with no exercise habits (controls)
Participant flow
[Athletes group]
Initial number of subjects: 24, including 2 dropouts (because they stopped participating in club activities)
[Cotrol group]
Initial number of subjects: 10, no drop-out
Adverse events
none
Outcome measures
Body fat, lean body mass, thicknesses of skeletal muscle (sum of anterior and posterior upper arm, abdomen, anterior and posterior thigh), subcutaneous fat (sum of directly above each skeletal muscle), and abdominal cavity, blood properties related to glucose and lipid metabolism, diversity of intestinal microbiota, and relative occupancy at genus level of major gut bacteria.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation period: 6 months
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053593
