UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028554 |
|---|---|
| Receipt number | R000032680 |
| Scientific Title | Influence of lactoferrin on mental and physical changes accompanying rugby training camp: a randomized, double-blind, parallel-group, placebo-controlled study |
| Date of disclosure of the study information | 2017/08/06 |
| Last modified on | 2017/09/13 16:25:08 |
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Basic information
Public title
Influence of lactoferrin on mental and physical changes accompanying rugby training camp: a randomized, double-blind, parallel-group, placebo-controlled study
Acronym
Influence of lactoferrin on mental and physical changes accompanying rugby training camp
Scientific Title
Influence of lactoferrin on mental and physical changes accompanying rugby training camp: a randomized, double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym
Influence of lactoferrin on mental and physical changes accompanying rugby training camp
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of ingesting lactoferrin on mental and physical changes accompanying the summer camp of university rugby players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fecal microbiota (Pre, 1 wk, 2wk)
Key secondary outcomes
Plasma metabolome, Responses of autonomic nerves system and salivary stress markers to calculation task
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Lactoferrin (900 mg/d) for 2 weeks
Interventions/Control_2
Placebo for 2 weeks
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1) A healthy male university rugby player
2) Subjects who have given voluntary, written, informed consent to participate in the study.
Key exclusion criteria
1) Subjects receiving treatment (medicine prescription by a doctor)
2) Subjects suffering from serious cardiovascular disorder, liver function disorder, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, or those having history of them
3) Subjects with history of chest pain or fainting.
4) Subjects who are likely to cause allergies related to the test supplement
5) Subjects who donated 200 mL within 1 month prior to the start of the study, or 400 mL (blood donation etc.) within 3 months
6) Subjects who habitually takes lactoferrin
7) Smokers
8) Subjects who has seasonal allergic disease (cedar, Japanese cypress, etc.)
9) Subjects who have participated in other clinical trials within the past 3 months or who are currently participating in other clinical trials
10) Subjects who are judged as unsuitable for this study by physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
Address
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL
+81-476-98-1001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
Address
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL
+81-476-98-1001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Health & Sports Science
Institute
Department
Personal name
Funding Source
Organization
The Grant of Cross-Ministerial Strategic Innovation Promotion Program (SIP).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Morinaga & Co., Ltd (Tokyo, Japan)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北見モイワスポーツワールド（北海道）、順天堂大学さくらキャンパス(千葉県）
Kitami Moiwa Sports World (Hokkaido, Japan)/ Juntendo University Sakura Campus (Chiba, Japan)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 06 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032680
