healthy individuals
Conditions
Interventions
Oral intake of test drink for 12 weeks
Not intake
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Hokkaido University of Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects who are healthy men and women aged 40 to under 64 (2) Subjects who feel fatigue (3) Subjects who have trouble with defecation (4) Subjects who have received sufficient explanation about the purpose and content of the study, have the ability to consent, have voluntarily understood, volunteered to participate, and agreed to participate in the study in writing
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of liver disease, kidney disease, gastrointestinal disease, heart disease, or other diseases that may affect the results of this study, or subjects with a history of surgery (2) Subjects with a disease currently being treated (3) Subjects with food and drug allergies (4) Subjects who have a habit of eating and drinking (5) Those who play intense sports and subjects who are on a diet (6) Subjects taking health foods and medicines that are expected to improve immunity and bowel movement (7) Subjects who may overdose food with a bowel movement improving effect during the study period (8) Subjects with anemia (9) Subjects whose life is irregular (10) Subjects who can not quit the intake of health food (including food for FOSHU and Foods with Function Claims') and designated quasi-drugs during the test period (11) Subjects who are taking medication (OTC drugs, including prescription drugs) continuously (12) Subjects who are excessively consuming alcohol or subjects who cannot ban alcohol from the day before the test to the day (13) Pregnant subjects or subjects who plan to become pregnant or breastfeed during the study period (14) Subjects who have participated in other clinical studies within 4 weeks from the start of this study, subjects who are currently participating in or plan to participate in the study (15) Subjects whose stool volume is equivalent to 1 or less quail eggs (16) Other subjects judged by the investigator as inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma metabolome analysis Natural killer cell activity Defecation status | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale Chalder's fatigue scale Profile of Mood States 2nd Edition (Fecal metabolome analysis, Fecal IgA, *Consider whether the analysis will be performed after the test.) | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed