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 |
Effects of Yogurt Fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Effects of Yogurt on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Effects of Yogurt Fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Effects of Yogurt on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Japan |
N/A (healthy adults)
Adult |
Others
NO
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.
Safety,Efficacy
[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)
[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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Other |
Oral intake of the test drink (100mL in a day; 12 weeks)
Oral intake of the placebo drink (100mL in a day; 12 weeks)
30 | years-old | <= |
49 | years-old | >= |
Male
[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.
[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.
50
1st name | |
Middle name | |
Last name | Shuji Nakata |
Medical Corporation Bokushinkai CLINTEXE Clinic
Director
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
03-6801-8480
info@tes-h.co.jp
1st name | |
Middle name | |
Last name | Ryoma Shimizu |
TES Holdings Co., Ltd
Administrative Department of Clinical Trials
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
03-6801-8480
r.shimizu@tes-h.co.jp
TES Holdings Co., Ltd
Meiji Co., Ltd.
Profit organization
NO
2017 | Year | 01 | Month | 31 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 21 | Day |
2015 | Year | 06 | Month | 27 | Day |
2017 | Year | 01 | Month | 05 | Day |
2017 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029237