Healthy adults whose VFA is >
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 whose VFA>=80cm2 by screening test. 4.Subjects whose blood serum beta-cryptoxanthin<50mcg/dL by screening test. 5. 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 disease. 2.Subjects who have a serious injury or surgical history within 12weeks 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. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 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 donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study. 9. Subjects who are pregnant or lactating, or subjects who 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 four weeks prior to this study. 12.Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in VFA between pre-ingestion and at four weeks of ingestion of Ripe Kumquats "Tama-Tama". | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The actual values and the change of VFA: at pre-ingestion and each evaluation points (4weeks and 8weeks ingestion of Ripe Kumquats "Tama-Tama"). 2.The actual values and the change of blood serum beta-cryptoxathin: at pre-ingestion and each evaluation points. 3.The actual values and the change of BMI, waist circumference and body composition analysis: at pre-ingestion and each evaluation points. 4.The actual values and the change of fatigue related scales:total score of Chalder fatigue scale, VAS scores, salivary amylase level: at pre-ingestion and each evaluation points. 5.The actual values and the change of Healthy QOL scales: at pre-ingestion and each evaluation points. 6.The actual values and the change of Natural killer cell activity level: at pre-ingestion and each evaluation points. 7.The actual values and the change of AGEs score: at pre-ingestion and each evaluation points. 8.The actual values and the change of glycolipid metabolism related index (HOMA-IR, glucose, insulin, HbA1C, triglyceride, free fatty acid level, HDL-cholesterol, LDL-cholesterol and uric acid) :at pre-ingestion and each evaluation points. 9.Adverse events. | — |
Countries
Japan
Contacts
Public ContactYasuji Arimura
University of Miyazaki Clinical research support center, University of Miyazaki hospital
Outcome results
None listed