UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041850 |
|---|---|
| Receipt number | R000047774 |
| Scientific Title | Effects of nutritional condition, body composition and physical ability by continuous ingestion of soy-protein drink in athletes -parallel-group comparative study- |
| Date of disclosure of the study information | 2020/09/20 |
| Last modified on | 2021/08/31 17:21:53 |
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Basic information
Public title
Effects of nutritional condition, body composition and physical ability by continuous ingestion of soy-protein drink in athletes
Acronym
Effects of continuous ingestion of soy-protein drink in athletes
Scientific Title
Effects of nutritional condition, body composition and physical ability by continuous ingestion of soy-protein drink in athletes -parallel-group comparative study-
Scientific Title:Acronym
Effects of continuous ingestion of soy-protein drink in athletes -parallel-group comparative study-
Region
| Japan |
Condition
Condition
athlete
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine improvement effects of soy-protein drink intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body composition(from absorption starting, 12 weeks later)
Key secondary outcomes
physical ability
blood test
(amino acid fraction)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
soy-protein drink
a morning and evening 200 ml every day for 12 weeks
Interventions/Control_2
ordinary milk
a morning and evening 200 ml every day for 12 weeks
Interventions/Control_3
no treatment
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
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
The 19 years old or 20 year old generation male athletes who have entered dormitory
The persons can drink the soy-protein drink or milk continually in the test period.
The persons have given written consent to participate from himself and his guardian(if underage).
Key exclusion criteria
Allergic to soybean, soymilk, milk
Others, whom have judged to be impossible to participate
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yukizane |
Organization
Nakagawa Hospital
Division name
surgery
Zip code
811-1345
Address
2-17-17, Mukaishinmachi, Minami-ku, Fukuoka
TEL
092-565-3531
taka1956-mh1118@lion.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yukito |
| Middle name | |
| Last name | Higuchi |
Organization
Kyushu Kyoritsu University
Division name
Department of Sports Science
Zip code
807-8585
Address
1-8, Jiyugaoka, Yahata-nishi-ku, Kitakyushu
TEL
093-693-3313
Homepage URL
higuchi@kyukyo-u.ac.jp
Sponsor or person
Institute
Kyushu Kyoritsu University
Institute
Department
Personal name
Funding Source
Organization
FUJI OIL CO., LTD
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
Kyushu Kyoritsu University Ethics Review Committee
Address
1-8, Jiyugaoka, Yahata-nishi-ku, Kitakyushu
Tel
093-693-3046
r-sakae@fains.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
九州共立大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 20 | 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
43
Results
After 12 weeks of treatment, we found no significant difference between three groups in the SMI. However, after 12 weeks of treatment, SMI were significantly higher in the soy-protein group, when compared to the baseline values.
Results date posted
| 2021 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male athletes who have entered dormitory
Participant flow
48 subjects who consented to the study were divided into 14 in the soy-protein group, 15 in the milk group and 14 in the control group, except five secession people.
Adverse events
Digestive symptoms
Outcome measures
SMI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047774
