Effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal wome
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048821
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method