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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025532
Receipt No. R000029237
Scientific Title Effects of Yogurt Fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Date of disclosure of the study information 2017/01/31
Last modified on 2017/01/05

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Basic information
Public title Effects of Yogurt Fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Acronym Effects of Yogurt on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Scientific Title Effects of Yogurt Fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Scientific Title:Acronym Effects of Yogurt on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Region
Japan

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

Objectives
Narrative objectives1 This study examines effects of yogurt fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Natural killer cell activity (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
[2]Questionnaires (Visual Analogue Scale, Face Scale, Profile of Mood States [Japanese version], fatigue questionnaire) (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
Key secondary outcomes [1]Lymphocyte blastoid transformation (PHA) (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
[2]Ghrelin (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
[3]Autonomic nerve function (heart rate [beats per minute], LF/HF(-), TP [msec2], ccvTP [%]) (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
[4]Laboratory values (hematologic test, blood biochemical test, urine analysis) (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)
[5]Subject's diary(From the first day of ingestion of a test material to the last day of the test)
[6]Doctor's questions (Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Oral intake of the test drink (100mL in a day; 12 weeks)
Interventions/Control_2 Oral intake of the placebo drink (100mL in a day; 12 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
49 years-old >=
Gender Male
Key inclusion criteria [1]Individuals whose written informed consent has been obtained.
[2]Males aged 30-49 years.
[3]Individuals who notice any symptoms by suffering from summer heat (whole-body tiredness, feeling of fatigue, accumulated fatigue).
[4]Individuals who are a day shift person (5-day and over 40 hours per week).
[5]Individuals who are a desk worker.
[6]Individuals who are a non-smoker
[7]Individuals whose dietary habit is stable (checking with questionnaires for life habit).
[8]Individuals whose BMI is 18.5-29.9.
Key exclusion criteria [1]Individuals using medical products or getting outpatient treatment.
[2]Individuals who have a history of serious disease having influence to study results.
[3]Individuals who are immunodeficient.
[4]Individuals who are or were patient with malignancy.
[5]Individuals who have a habit to intake fermented milk or lactic acid bacteria beverage in the past 3 months.
[6]Individuals who had a habit to ingest health-promoting drugs, quasi drugs, foods, foods for specified health uses, health foods, or supplements (ex. antibiotic drug, laxative, antiflatulent, or foods containing oligosaccharide, dietary fiber, lactic acid bacteria) in the past 3 months or will ingest those foods during the test period.
[7]Individuals who are sensitive to dairy products or intolerant to lactose.
[8]Individuals who are sensitive to foods, and medical products.
[9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[10]Indiviuals who are an itinerant sales person or manual laborer.
[11]Individuals who participated in other clinical studies in the past 1 month.
[12]Individuals judged inappropriate for the study by the principal or subinvestigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Nakata
Organization Medical Corporation Bokushinkai CLINTEXE Clinic
Division name Director
Zip code
Address 4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL 03-6801-8480
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd
Division name Administrative Department of Clinical Trials
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 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 05 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 27 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 01 Month 05 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029237

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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