None listed
Conditions
Interventions
Oral intake of lactic acid bacteria (one tablet per day for 12 weeks)
Oral intake of placebo (one tablet per day for 12 weeks)
Sponsors
House Wellness Foods Corporation Research and Development Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female subjects whose ages are from 20 to 75 years old (2) Healthy subjects whose BMI values are more than 23 but less than 30 (3) Subjects who participate in this study with a written informed consent
Exclusion criteria
Exclusion criteria: (1) Subjects who have symptoms of allergic rhinitis or bronchial asthma (2) Subjects who plan to have medications that may affect the results during this clinical trial. (3) Subjects who have consumed the lactic acid bacteria used in this clinical trial on a daily basis (4) Subjects who are in pregnant or plan to get pregnant, or who are breastfeeding (5) Subjects who have a history of diabetes, hepatic diseases, kidney diseases, cardiac diseases, gastrointestinal diseases, circulatory diseases or the other diseases (6) Subjects who drink excessive alcohol or smoke heavily (7) Subjects who are at risk of having allergic symptoms to test product of this clinical trial (8) Subjects who have extremely irregular dietary habit, and have irregular life rhythm such as shift or midnight workers (9) Subjects who are participating in the other clinical trial, or have participated in the other one during the past 4 weeks, or plan to enroll in the other one during scheduled period in this trial (10) Subjects who have made a component blood donation or a blood donation of 200 mL within the last one month prior to this clinical trial (11) Male subjects who have made a blood donation of 400 mL within the last three months prior to this clinical trial (12) Female subjects who have made a blood donation of 400 mL within the last four months prior to this clinical trial (13) Male subjects who have made a blood donation in amounts greater than 1,200 mL including the estimated volume of blood sampling in this clinical trial within the last one year prior to this clinical trial (14) Female subjects who have made a blood donation in amounts greater than 800 mL including the estimated volume of blood sampling in this clinical trial within the last one year prior to this clinical trial (15) Subjects judged as unsuitable for this clinical trial by the investigator or sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the 0th, 4th, 8th and 12th week of the intervention (1) Concanavalin A induced T cell proliferation (2) Th1/Th2 ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| At the 0th, 4th, 8th and 12th week of the intervention (1) C-reactive protein (CRP) (2) Interleukin (IL)-1beta (3) Tumor necrosis factor (TNF)-alpha (4) Visceral fat area (5) Questionnaire survey (POMS2 short version) (6) Questionnaire survey (SF-36v2 standard edition) (7) Questionnaire survey (WURSS-21 Japanese version) (8) Blood glucose level (9) Cholesterol level | — |
Countries
Japan
Contacts
Public ContactYusuke Tanaka
House Wellness Foods Corporation Research and Development Institute
Outcome results
None listed