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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025974
Receipt No. R000029857
Scientific Title Anti-fatigue Effects of Yogurt Fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1.
Date of disclosure of the study information 2017/02/02
Last modified on 2018/01/19

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Basic information
Public title Anti-fatigue Effects of Yogurt Fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1.
Acronym Anti-fatigue Effects of Yogurt
Scientific Title Anti-fatigue Effects of Yogurt Fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1.
Scientific Title:Acronym Anti-fatigue Effects of Yogurt
Region
Japan

Condition
Condition N/A (healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-fatigue effects of yogurt fermented with Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Autonomic nerve function
[2]Cognitive function
[3]Subjective Fatigue
Key secondary outcomes [1]Condition of sleep
[2]Physical active mass
[3]Fatigue biomarker in blood

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 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 Oral intake of the test food (112 mL) twice a day for 4 weeks.
Washout period for 3 weeks.
Oral intake of the placebo (112mL) twice a day for 4 weeks.
Interventions/Control_2 Oral intake of the placebo (112 mL) twice a day for 4 weeks.
Washout period for 3 weeks.
Oral intake of the test food (112mL) twice a day for 4 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
30 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria [1]Individuals whose written informed consent has been obtained.
[2]Healthy adults aged 30-59 years.
Key exclusion criteria [1]Individuals under medication or using medial products.
[2]Individuals who have medical history of circulatory system diseases.
[3]Individuals who have autonomic nervous system disorders.
[4]Individuals who have medical history of neurological diseases such as unconsciousness, coma, convulsion, etc.
[5]Individuals who have sleep disorders.
[6]Individuals who have serious diseases such as diabetes, liver diseases, renal diseases, heart diseases.
[7]Individuals who have serious pollinosis.
[8]Individuals who are sensitive to foods or intolerant to lactose.
[9]Individuals who excessively take alcohol(expressed in amount of alcohol: over 60 g/day)
[10]Smokers.
[11]Individuals who have a habit to take fermented milk or lactic acid bacteria beverage two days a week or more in the past 3 months.
[12]Individuals who work the night shift.
[13]Individuals whose BMI is not 17.0-30.9.
[14]Individuals who have meal restrictions.
[15]Women who are pregnant, breastfeeding, or wish to be pregnant in this study period.
[16]Individuals who participated in other clinical trials in the past 1 month or are going to participate in other trials in this study period.
[17]Individuals who are judged not suitable to participate in this trial by investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, North Building, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL +81-6-6485-0288
Email chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Furusawa
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, North Building, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL +81-6-6485-0288
Homepage URL
Email chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute Center for Health Science Innovation, Osaka City University
Institute
Department

Funding Source
Organization Meiji 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
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 大阪市立大学健康科学イノベーションセンター(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 02 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 03 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 02 Month 02 Day
Last modified on
2018 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029857

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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