Healthy adults.
Conditions
Interventions
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who have no abnormality in clinical problems by screening tests. 3. Subjects who have less than 50mcg/dL blood concentration of beta-cryptoxanthin on screening tests day. 4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 3. Pre- or post-menopausal women having obvious changes in physical condition. 4. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 5. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 6. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 7. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 8. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within four weeks or blood components within two weeks prior to this study. 9. Pregnant or lactating women or women expect to be pregnant during this study. 10. Subjects who have cognitive disorder or who have possibility of the disorder. 11. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentrations of beta-cryptoxanthin on the first day, 8th day, 29th day and eight weeks after ingestion of Ripe Kumquats "Tama-Tama". | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Natural killer cell activity 2. Interleukin-6 values 3. Body Mass Index 4. Body composition (muscle mass, fat content, body fat percentage), visceral fat area 5. Concentration of salivary amylase 6. Fatigue related scales 7. QOL scales(SF-36) 8. Adverse events. (The secondary outcomes 1 to 5 are assessed on the first day, 8th day, 29th day and eight weeks after ingestion , and the outcomes 6 and 7 are assessed on the first day, 29th day and eight weeks after ingestion.) | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospital
Outcome results
None listed