Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Active food 1 Administration: Dissolve one packet in water and drink it once daily after breakfast. *If you forget to take the test food, take it as soon as you reme
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 50 or more 4. Healthy subjects 5. Subjects who are natural menopause for at least one year 6. Subjects whose BMI are 18.5 kg/m2 or more and less then 25 kg/m2 at screening (before consumption)
Exclusion criteria
Exclusion criteria: Subjects who 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator 3.are currently undergoing treatment for chronic diseases (e.g., arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, or hypertension) 4.take "Foods for Specified Health Uses," or "Foods with Functional Claims" daily 5.are currently taking medicines (including herbal medicines) and supplements 6.usually take food/beverage with functional ingredients which may influence skin, bone metabolism, muscle, or exercise (e.g., GABA, isoflavone, lactic acid bacteria, bifidobacteria, EPA, DHA, astaxanthin, glucosylceramide, proteoglycans, glucosamine hydrochloride, MCT, collagen peptide, gallated catechin, imidazole dipeptide, calcium, or vitamin D or K) 7.take foods with gelatin or collagen peptides (e.g., jelly or gummy) daily / must take this during this trial 8.are allergic to medicines and/or the test food related products 9.are pregnant, lactating, or planning to become pregnant during this trial 10.suffer from COVID-19 11.have been enrolled in other clinical trials for the last 28 days before the agreement to participate or plan to participate another trial during this trial 12.are judged as ineligible by the physician 13.have been diagnosed with atopic dermatitis 14.habitually receive skincare treatment (e.g., aesthetic treatment) or use devices for beauty treatment (e.g., facial treatment device) 15.have undergone cosmetic surgery 16.are undergoing or need to undergo treatment for knee or waist disease (e.g., osteoarthritis) 17.have undergone or need to undergo knee or back surgery 18.may experience rheumatic pain 19.are attending an orthopedic or osteopathic clinic 20.intensely exercise to put load on their body 21.have osteoporosis (YAM score of total amount of lumbar vertebra less than 70%) 22.receive hormonal therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal water loss, dermis measurement {intensity, skin thickness, the low echogenic band (LEB)}, each items {bone area, bone mineral density, T-score, Young Adult Mean (YAM) score, and Z score} of lumbar vertebra (L2, L3, L4, total amount) and left femur (neck, trochanter, and total amount), the number of times of standing up from the chair for 30 seconds, grip strength, weight, body mass index (BMI), body fat percentage, body fat mass, lean mass, muscle mass, and each following measurement in the blood: bone-specific alkaline phosphatase (BAP), total type I procollagen-N-propeptide (total P1NP), cross-linked N-telopeptide of type I collagen (NTx), and tartrate-resistant acid phosphatase 5b (TRACP-5b) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed