UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Yogurt Fermented with Lactobacillus delbrueckii ssp. bulgaricus OLL1073R-1 on Immune Markers and Unidentified Complaints Caused by Suffering from Summer Heat
Title of the study (Brief title)	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	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Director
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	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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