Safety Assessment of a Functional Food in Healthy Volunteers
Conditions
Interventions
Test product Duration of test food intake 4 weeks
Sponsors
BEYOND KAMPO Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 20 to 65 years at the time of obtaining consent to participate in the study. 2) Individuals suffering from chronic constipation and abdominal pain, bloating, or discomfort. 3) Individuals without chronic physical illnesses, including skin diseases. 4) Individuals who have received a full explanation of the purpose and content of the study, are competent to consent, fully understand the content, and voluntarily volunteer to participate and provide written consent. 5) Individuals who are able to attend the study on the designated date and undergo the examination.
Exclusion criteria
Exclusion criteria: 1) Those currently suffering from any illness and receiving drug treatment. 2) Those with a history or current illness of mental illness, sleep disorder, hypertension, diabetes, dyslipidemia, or other serious illnesses. 3) Those who have taken medication for the purpose of treating an illness within the past month (excluding those taking medication for headaches, menstrual pain, colds, etc.). 4) Those with a history or current serious illness involving the liver, kidneys, heart, lungs, blood, etc. 5) Those with a history or current serious coexisting illness involving the digestive system. 6) Subjects with drug or food allergies 7) Subjects currently or in the past month regularly consuming foods for specified health uses, foods with functional claims, or health foods 8) Subjects who regularly consume fermented foods rich in lactic acid bacteria (e.g., cheese, yogurt, kimchi, and soybeans) 9) Subjects whose daily alcohol intake exceeds 30g of pure alcohol per day 10) Subjects who may change their lifestyle during the study period (e.g., long-term travel) 11) Pregnant, nursing, or potentially pregnant during the study period. 12) Currently participating in another human clinical trial, or within the last three months since participating in another human clinical trial. 13) Other individuals who the investigator deems inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence of adverse events will be assessed based on Number and incidence rate of adverse events (number of subjects with adverse events / number of subjects included in the safety analysis set) | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematology and blood chemistry tests (hematological and biochemical parameters) Urinalysis Quality of life (QOL), stool characteristics, bowel movement frequency | — |
Countries
Japan
Contacts
Public ContactRyuji Takasaki
BEYOND KAMPO Inc. Director
Outcome results
None listed