Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Soft capsule containing SACS10 Administration: Take two capsules with water once a day *If you forget to take the test food, take it as soon as you remember. The dai
Sponsors
NH Foods Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose LDL-Cho is between 120 mg/dL and 139 mg/dL at Scr
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking or using medications (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product 7. usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 8. usually engage in physical activity of 6.0 METs or more (such as high-intensity weight training, exercise with shortness of breath, or sports) 9. have irregular sleeping time or habit due to work such as a late-night shift 10. have irregular lifestyles (such as inconstant eating time, insufficient sleeping time) 11. have a medical history of rhabdomyolysis 12. have a medical history of dyslipidemia and were taking medication 13. are pregnant, lactating, or planning to become pregnant during this study 14. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of low-density lipoprotein cholesterol (LDL-Cho) at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage change from screening (Scr) and logarithmic value of LDL-Cho at 12w 2. The measured values of total cholesterol (T-Cho), high-density lipoprotein cholesterol (HDL-Cho), triglyceride (TG), and LDL-Cho/HDL-Cho (LH ratio) at 12w, and the percentage changes from Scr and logarithmic values of them 3. The measured values of subjective fatigue measured by visual analogue scale (VAS), body weight, body mass index (BMI), body fat percentage, lean body mass, fat mass (whole body, right leg, left leg, right arm, left arm, and trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), Total Mood Disturbance (TMD) score, Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), Vigor-Activity (VA), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed