Healthy male/female adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Male or female employees of HOKUTO Group (HOKUTO Corporation or Hokuto Industry Corporation) who are aged 20 years or older at the time of informed consent. (2) Subjects who receive explanation about the study, are able to understand the contents, and provide written informed consent by themselves.
Exclusion criteria
Exclusion criteria: (1) Individuals who have taken medications that may affect the gut environment (e.g., antibiotics, intestinal regulators, laxatives) within 1 month prior to starting intake of the test food, or who cannot restrict such use during the study. Use for hay fever is permitted. (2) Individuals who are currently participating in another clinical trial of drugs or health foods, within 4 weeks after completing another trial, or who plan to participate in another clinical trial after consenting to this study. (3) Individuals with excessive alcohol consumption. (4) Individuals who have undergone surgery within 6 months prior to consent that may affect the study (e.g., colorectal endoscopic surgery, cholecystectomy for gallstones, gastric bypass). (5) Individuals with a history or current serious disease of the heart, liver, kidneys, or gastrointestinal tract. (6) Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period. (7) Individuals with a mushroom allergy or who cannot tolerate mushrooms. (8) Individuals judged by the principal investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal metabolites (short-chain fatty acids and organic acids) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Defecation status (the number of days, frequency, property, feeling of incomplete evacuation, abdominal pain) 2Presenteeism 3Subjective health status 4Body weight | — |
Countries
Japan
Contacts
HOKUTO Corporation R & D