UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025532 |
|---|---|
| Receipt number | 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 10:56:48 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029237
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| Registered date | File name |
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