Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: SG-1 Administration: Take one tablet with water 30 minutes before each meal (breakfast, lunch, and dinner), for a total of three tablets per day. *The daily dose
Sponsors
Bio Actives Japan Corporation.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 23 or more and less than 30 at Scr 6. Individuals whose waist circumference is relatively large at Scr
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, particularly those allergic to herbs 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. 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 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of body mass index (BMI) at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and percentage of change in BMI from screening (Scr) at 12w 2. The measured values of body weight, body fat percentage, lean body mass, muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), and waist circumference at 12w, and their amount and percentage of changes from Scr 3. The measured values of "sleepiness on rising (Zc score)," "initiation and maintenance of sleep (Zc score)," "frequent dreaming (Zc score)," "refreshing (Zc score)," "sleep length (Zc score)," Chalder Fatigue Scale (CFS) total score, physical fatigue score, and mental fatigue score at 12w 4. The measured values of the defecation frequency, defecation days, and the amount of defecation in period 2~13* 5. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 2~13 compared to period 1* 6. Individuals whose response to "not good at relieving tension," "nerves are quite sensitive," "cannot relax," "do not feel positive," "no feeling of satiety after eating," "no feeling of fullness after eating," "no feeling of hunger before eating," "skin is rough," "skin is itchy," "wrinkles are noticeable," "stains are noticeable," "acne is noticeable," "pores are noticeable," "skin is dry," "face is swollen," "skin lacks firmness and elasticity," "skin lacks clarity," and "makeup does not apply well" improved by one or more scales at 12w compared to Scr 7. The measured values of Pain, Water Reten, Auto React, Neg Affect, Impair Conc, Behave Change, Arousal, and Control at 12w, and their amount and percentage of changes from before intervention 8. Individuals whose response to each item in the Menstrual Distress Questionnaire (MDQ) improved by one or more scal | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed