Unique ID issued by UMIN | UMIN000048821 |
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Receipt number | R000055633 |
Scientific Title | Effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal women: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/09/01 |
Last modified on | 2024/04/12 09:14:02 |
Effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal women
Effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal women
Effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal women: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal women
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To conduct exploratory verification of the effects of consumption of the test food on the skin and joints in healthy Japanese postmenopausal women
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
3
Treatment
Food |
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 remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Test food: Active food 2
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 remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Test food: Placebo food
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 remember. Daily dose should be taken within the day and not carried over to the next day.
50 | years-old | <= |
Not applicable |
Female
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)
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
15
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
TOKYO KASEI UNIVERSITY
Other
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2022 | Year | 09 | Month | 01 | Day |
Unpublished
18
Completed
2022 | Year | 08 | Month | 24 | Day |
2022 | Year | 08 | Month | 24 | Day |
2022 | Year | 09 | Month | 01 | Day |
2023 | Year | 02 | Month | 04 | Day |
2022 | Year | 09 | Month | 01 | Day |
2024 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055633
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