Healthy adults
Conditions
Interventions
Duration: 12 weeks Test product: Product containing Administration: Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water. *If a take is mis
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose HbA1c is 5.6% or more and less than 6.5% at screening before intervention
Exclusion criteria
Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medications or foods related to the test product, particularly those allergic to citrus fruits 7. Individuals who are pregnant, lactating, or planning pregnancy during this study 8. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of HbA1c at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The changes and percentage changes from screening (Scr) of HbA1c at 12w 2. The measured values of glucose, insulin, and HOMA-IR at 12w, as well as their changes and percentage changes from Scr 3. The measured values of skin dullness, skin color, memory loss, concentration, attention, physical strength, feeling of fatigue, endurance, vitality, agility at 12w, as well as their changes and percentage changes from Scr 4. The measured values of pentoxazine in blood at 12w, as well as their changes and percentage changes from Scr 5. Individuals who experienced adverse events 6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 7. Physical measurements, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed