Effects of long term ingestion of lactic acid bacterium-containing food on sleep and defecation. Placebo-controlled double-blind randomized crossover comparative study
- Conditions
- healthy humans
- Registration Number
- JPRN-UMIN000024806
- Lead Sponsor
- Miura Clinic, Medical Corporation Kanonkai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method