healthy humans
Conditions
Interventions
Oral ingestion of lactic acid bacterium-containing food twice a day for 12 weeks
Oral ingestion of the placebo control food twice a day for 12 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 20<=Age<64 of healty men and women (2) Subjects with a problem for their sleeping (3) Subjects with a problem for their bowel movements
Exclusion criteria
Exclusion criteria: (1) Subjects with a medical history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or severe diseases (2) Subjects with a disorder in heart and lung function (3) Subjects with abnormal parameters in liver or kidney function (4) Subjects who had a gastrointestinal surgery (5) Subjects with a disease currently under treatment (6) Subjects with drug or food allergies (7) Subjects who play high intensity sports or are on a diet (8) Subjects who are taking supplemental food, quasi drags on drug products (including OTC prescribed medication) that are expected to have improvement effects on bowel movement and sleeplessness (9) Subjects who drink excessive alcohol, or who cannot stop drinking alcohol for a measurement period of brain waves during sleep and the Actigraph, one day prior to the test day and the day of the test (10) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period (11) Subjects who is participating in the other study or planning to participate during the study period (12) Subjects deemed unsuitable by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain waves during sleep OSA sleep inventory MA version Visual Analogue Scale Number of bowel movements The days of bowel movements observed Form of stool Amount of stool | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness support Co., Ltd. Clinical trial Division
Outcome results
None listed