N/A (healthy adults)
Conditions
Interventions
Oral intake of the test drink (100mL in a day
12 weeks)
Oral intake of the placebo drink (100mL in a day
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [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) | — |
Secondary
| Measure | Time frame |
|---|---|
| [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) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed