UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028554
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Health & Sports Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032680

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.