Healthy subjects
Conditions
Interventions
Duration: eight weeks Test device: AbsFit1 Administration: Before using, put a jelly-seat on the electrode part of the device. Put the device with the jelly-seat on the abdomen (between under rib an
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. General healthy subjects 2. Subjects who age between 20 or more and less than 70 when they provide written informed consent 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who do not show discomfort and aversion with electrical stimulation by the test devices 5. Subjects between 18.5 and 25 in body mass index (BMI) 6. Within the subjects who met the first to fifth inclusion criteria, six or more male and six or more female are selected from each generation
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a cardiac disorder or potential one 3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 4. Subjects who have a metal such as a joint prosthesis, clips, and so on. 5. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. Subjects who have a wound on the skin of the target part 7. Subjects who have been diagnosed with epilepsy 8. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 9. Subjects who are currently taking food and supplements affecting muscular hypertrophy such as protein, amino acids, and 3-Hydroxy 3-MethylButyrate (HMB) 10. Subjects who have exercise habits or muscular workouts more than two times per week 11. Subjects who are required to be placed at rest 12. Subjects who have an acute painful disease such as spine fractures, sprains, and flesh breaks 13. Currently taking medicines (include herbal medicines) and supplements 14. Subjects who have metal allergy 15. Subjects who cannot understand the method of application of test device 16. Subjects who are pregnant, breast-feeding, and planning to become pregnant 17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 18. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value and changes of the following items at four, eight and 12 weeks after the start of using the devices: the muscle cross section of umbilical region and muscle thickness of each part of rectus abdominis muscle, biceps brachii muscle, triceps brachii muscle and quadriceps femoris | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured value and changes of the following items at four, eight and 12 weeks after the start of using the devices: body weight, BMI, body fat percentage, body temperature, fat mass, lean body mass, muscle mass* *Whole body, trunk, left arm, right arm, left leg and right leg | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed