Healthy male/female volunteers
Conditions
Interventions
High daily intake of test food, continuous for 4 weeks
Low daily intake of test food, continuous for 4 weeks
Control food consumed continuously for 4 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese men and women who are at least 20 years old and less than 65 years old at the time consent is obtained. (2) Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate in the research based on sufficient understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Exclusion criteria
Exclusion criteria: (1) Those who have serious renal or hepatic disease, cardiac, respiratory, endocrine, or other metabolic diseases, or are under treatment for such diseases. (2) Those who have chronic diseases and use medicines regularly. (3) Those who have gastrointestinal diseases affecting digestion and absorption and those who have a history of gastrointestinal surgery (except appendicitis). (4) Those who cannot stop taking supplements or health foods (including food for specified health uses and functional foods) during the research period. (5) Those who have a history or current medical history of drug dependence or alcohol dependence. (6) Those who are unable to stop drinking alcohol for 2 days prior to all tests. (7) Those who are judged by the principal investigator to be unsuitable as research subjects based on blood tests performed during the screening tests. (8) Those who have reported that they are allergic to any of the ingredients of the study foods. (9) Those who are currently participating in, or intend to participate in, research (studies) involving the ingestion of other foods or the use of drugs, or the application of cosmetics and medicines, or those who have participated in other clinical research within one month of obtaining consent. (10) Those who have donated blood or component blood more than 200 mL within 1 month or 400 mL within 3 months prior to the date of obtaining consent. (11) Those who are pregnant, intend to become pregnant during the study period, may become pregnant, or are breastfeeding. (12) Any other persons judged by the Principal Investigator to be inappropriate as research subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Questionnaire and subjective and objective symptoms (including adverse events and subjective symptoms recorded in the diary) 2. body weight (BMI) 3. Blood pressure and pulse rate 4. Clinical examination Hematology, biochemistry, urinalysis | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed