An open-label, uncontrolled exploratory study to investigate the efficacy assessment for function claims of Ripe Kumquats "Tama-Tama"
- Conditions
- The healthy adults who complain fatigue
- Registration Number
- JPRN-UMIN000020484
- Lead Sponsor
- niversity of Miyazaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
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. Subjects who are less than one (10mm) by VAS scale relating to their fatigue. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. 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. 8. Subjects with irregular lifestyle, such as diet and sleep (shift workers, late-night workers, etc). 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. 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. 11. Pregnant or lactating women or women expect to be pregnant during this study. 12. Subjects who have cognitive disorder or who have possibility of the disorder. 13. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 14. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method atural killer cell activity at baseline, one week, four weeks and eight weeks after ingestion of ripe kumquats.
- Secondary Outcome Measures
Name Time Method 1. Efficacy: immune function, adrenal function, glycometabolism, lipid metabolism, bone metabolism, energy metabolism, oxidation stress, spiritual stress, fatigue related scales and health related QOL. 2. Adverse events. 3. Blood concentrations of beta-cryptoxanthin. (They are assessed at at baseline, one week, four weeks and eight weeks after ingestion of ripe kumquats except adverse events.)