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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031319
Receipt No. R000035753
Scientific Title Effect of oral lactoferrin on psychological stress in humans: a randomized double-blind placebo-controlled cross-over trial
Date of disclosure of the study information 2018/02/16
Last modified on 2018/02/15

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Basic information
Public title Effect of oral lactoferrin on psychological stress in humans: a randomized double-blind placebo-controlled cross-over trial
Acronym Effect of oral lactoferrin on psychological stress
Scientific Title Effect of oral lactoferrin on psychological stress in humans: a randomized double-blind placebo-controlled cross-over trial
Scientific Title:Acronym Effect of oral lactoferrin on psychological stress
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of lactoferrin on psychological stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Autonomic nervous activity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
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 (800 mg) in 150 ml of soymilk, single administration
Interventions/Control_2 150 ml of soymilk, single administration
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 Female
Key inclusion criteria Subjects who was given explanation of this study, understood and agreed to its objective, and gave informed consent on a voluntary basis.
Key exclusion criteria (1) Subjects who are prescribed drug.
(2) Subject who suffers or suffered from serious cardiovascular, hepatic, renal, respiratory, endocrine, metabolic disorder.
(3) Subject who experienced chest pain or syncope.
(4) Subject who has allergy to test food.
(5) Subject who donated whole blood ,200ml within 1 month or 400ml within 3 month, before entry.
(6) Smokers
(7) Subjects who participate in other clinical trials within the last 3 month before entry.
(8) Subjects diagnosed as impaired glucose tolerance in the past year
(9) Subjects who are not eligible due to physician's judgment.
Target sample size 20

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
Institute
Department

Funding Source
Organization Cabinet Office, Government of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 16 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
2015 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 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
2018 Year 02 Month 15 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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