UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Juntendo University, Graduate School of Health & Sports Science

Institute

Department

Personal name

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

Co-sponsor

Morinaga & Co., Ltd (Tokyo, Japan)

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

08

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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