Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Food containing 5-aminolevulinic acid phosphate (5-ALA) Administration: Consume one tablet with water without chewing once daily *If a dose is missed, it should b
Sponsors
SBI ALApromo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 40 or more 4. Healthy individuals 5. Individuals whose BMI is >= 18.5 kg/m2 and < 30.0 kg/m2 at screening 6. Individuals who meet inclusion criteria 1-5 and have low resting metabolic rate at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 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 are taking "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 medicines or foods related to the test product 7. Individuals whose daily alcohol intake exceeds 60 g 8. Individuals who are shift workers, such as working a late-night shift or others 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who 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 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measured value of resting metabolic rate at 12 weeks after the intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change and percentage change in resting metabolic rate from screening at 12w 2. Measured values of resting respiratory quotient (VCO2/VO2), resting metabolic equivalents, resting glucose oxidation, resting carbohydrate oxidation, resting fat oxidation, resting basal metabolic rate, 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), abdominal circumference, and triglyceride (TG) at 12w, and their changes and percentage changes from screening 3. Average body temperature upon waking during the intervention period 4. Mitochondrial activity, biological age, aging rate, metabolic and inflammation-related protein indicators, environmental exposure indicators, physical function-related indicators, and cellular and molecular function indicators (telomere length) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed