Koji Product Supplementation' s Study (KPS)
2021年6月27日 更新者：National Taiwan University Hospital
The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly
The present project is to identify the effect of black soy beans Koji product supplementation on nutrients absorption and anti-aging effect in elderly.
調査の概要
詳細な説明
Previous studies show that supplementation of soy protein can effectively increase muscle mass and protein utilization.
Besides, soy extracts and isoflavones can stimulate muscle growth by activating the anabolic pathway of muscle tubules.
Black soybean is known to be rich in legume protein and isoflavones.We speculate that black soybean supplementation can improve the nutritional status and muscle mass of elderly people, thereby delaying the deterioration of muscular dystrophy in the elderly.
Reduce the occurrence of debilitation in the elderly.
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Taipei City、台湾、110
- Taipei Medical University
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
1-2 items are necessary, 3-5 can match one item
- Age above 65 years
- Oral intake
- Walking speed: ≤ 0.8 m/s (measured by time for a 5-meter usual gait)
- Handgrip strength: Men: <26 kg Women: <18 kg (measured by electronic hand grip dynamometer)
- Calf circumference: Men: ≤ 34 cm Women: ≤ 33 cm
Exclusion Criteria:
- Participant in a moderate or strenuous exercise
- Unable to walk
- Unable to take in food from the mouth
- People who can't record or communicate.
- Refuse to accept the 3-day diet record
- Allergic to black soybeans or legumes
- Allergic to egg or milk
- Infected with disease and had to be hospitalized for treatment before 4 weeks of the intervention test start
- A patient who has been diagnosed with a malignant tumor or has a history of malignancy in the past year.
- The estimated glomerular filtration rate (eGFR) is less than 60 ml/min/1.73 m2 in the past three months.
- Hypothyroidism
- People who often have symptoms of gastrointestinal upset.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Black soybean koji product
Oral supplement 2 servings of black soybean koji product per day, for 10 weeks.
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Black soybean koji product
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body mass index
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure body mass index (BMI).
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Change from baseline outcome measure at 10th week (post-test)
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Fat mass
時間枠：Change from baseline outcome measure at 10th week (post-test).
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Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure fat mass.
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Change from baseline outcome measure at 10th week (post-test).
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Muscle mas
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure whole body and appendicular skeletal muscle mass.
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Change from baseline outcome measure at 10th week (post-test)
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Visceral fat area(VFA)
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Visceral fat area(VFA) (cm2).
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Change from baseline outcome measure at 10th week (post-test)
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BIA - Basal Metabolic Rate(BMR)
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Basal Metabolic Rate(BMR) (kcal) . |
Change from baseline outcome measure at 10th week (post-test)
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whole body Mineral
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Mineral (kg) in whole body. . |
Change from baseline outcome measure at 10th week (post-test)
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Bone Mineral Content
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Bone Mineral Content (kg).
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Change from baseline outcome measure at 10th week (post-test)
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Cellular Water
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure whole body Extracellular Water (L), Intracellular Water(L), and Total Body Water (L), et al. . |
Change from baseline outcome measure at 10th week (post-test)
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Muscle Strength - Hand Grip Strength
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Using hand grips to measure hand grip strength.
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Change from baseline outcome measure at 10th week (post-test)
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Physical Performance - Walking Speed
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measuring participants' speed to walk 5 ft.
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Change from baseline outcome measure at 10th week (post-test)
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Gut Microbiota Composition Analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Total genome DNA from samples was extracted from stool samples using the CTAB/SDS method.
One hundred ng of DNA was amplified with barcoded primers16S V3+V4: 314F-806R annealing to the V3-V4region of the 16S rRNA.
All of the PCR reactions were carried out using a Phusion® High-Fidelity PCR Master Mix (New England Biolabs, Location).
Samples with a bright main strip between 400 and 450bp were selected from 2% agarose gel for further experiments.
Mixture PCR products were purified using a Qiagen Gel Extraction Kit (Qiagen, Germany).
Libraries were generated with the TruSeq® DNA PCR-Free Sample Preparation Kit and quantified with Qubit and Q-PCR.
The purified DNA was then sequenced using the HiSeq2500 PE250 (Company, Location).
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Change from baseline outcome measure at 10th week (post-test)
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Gut Microbiota -derived Metabolite Analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography.
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Change from baseline outcome measure at 10th week (post-test)
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Inflammatory Cytokines TNF-α Analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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The inflammation-associated serum cytokines TNF-α was analyzed using colorimetric kits (Company, Location).
Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits.
The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).
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Change from baseline outcome measure at 10th week (post-test)
|
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Inflammatory Cytokines IL-6 Analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
The inflammation-associated serum cytokines IL-6 was analyzed using colorimetric kits (Company, Location).
Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits.
The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).
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Change from baseline outcome measure at 10th week (post-test)
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Inflammatory Cytokines IL-1β Analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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The inflammation-associated serum cytokines IL-1β (BioLegend, City, State, USA) was analyzed using colorimetric kits (Company, Location).
Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits.
The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).
|
Change from baseline outcome measure at 10th week (post-test)
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Red blood cells analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of red blood cells( M/ul)
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Change from baseline outcome measure at 10th week (post-test)
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Hemoglobin analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
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Change from baseline outcome measure at 10th week (post-test)
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MCHC(g/dL) analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL)
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Change from baseline outcome measure at 10th week (post-test)
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Albumin analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Hematocrit analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
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Change from baseline outcome measure at 10th week (post-test)
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RDW-CV analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
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Change from baseline outcome measure at 10th week (post-test)
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HbA1C analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
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Change from baseline outcome measure at 10th week (post-test)
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MCV analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of MCV(fL).
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Change from baseline outcome measure at 10th week (post-test)
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MCH analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of MCH(pg).
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Change from baseline outcome measure at 10th week (post-test)
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Platelets analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
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Change from baseline outcome measure at 10th week (post-test)
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WBC analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
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Change from baseline outcome measure at 10th week (post-test)
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AST analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of AST(U/L).
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Change from baseline outcome measure at 10th week (post-test)
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ALT analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
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Change from baseline outcome measure at 10th week (post-test)
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GGT analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
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Change from baseline outcome measure at 10th week (post-test)
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T-Cholesterol analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Triglyceride analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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BUN analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Uric acid analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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HDL-C analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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LDL-C analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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hs-CRP analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of hs-CRP(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Fasting blood glucose analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of fasting blood glucose(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Creatinine analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Free T4 analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of 【Free T4(ng/dL)】
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Change from baseline outcome measure at 10th week (post-test)
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hsTSH analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
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Change from baseline outcome measure at 10th week (post-test)
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HOMA-IR analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
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Change from baseline outcome measure at 10th week (post-test)
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Insulin analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
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Change from baseline outcome measure at 10th week (post-test)
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eGFR analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of 【eGFR (mL/min/1.73^2)】
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Change from baseline outcome measure at 10th week (post-test)
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Ca analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
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Change from baseline outcome measure at 10th week (post-test)
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specific gravity index analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes specific gravity index (USG).
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Change from baseline outcome measure at 10th week (post-test)
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Urine pH analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes pH.
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Change from baseline outcome measure at 10th week (post-test)
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Urine total protein analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes Total protein (mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Urine glucose analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes glucose (-/+).
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Change from baseline outcome measure at 10th week (post-test)
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Urine Urea Nitrogen analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes Urine Urea Nitrogen(-/+).
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Change from baseline outcome measure at 10th week (post-test)
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Urine ketones analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes ketones(-/+).
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Change from baseline outcome measure at 10th week (post-test)
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Urine Creatinine analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes Creatinine(mg/dL).
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Change from baseline outcome measure at 10th week (post-test)
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Urine bilirubin (dipstick) analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes bilirubin (-/+).
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Change from baseline outcome measure at 10th week (post-test)
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Urine Albumin analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes Albumin(mg/L).
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Change from baseline outcome measure at 10th week (post-test)
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Urine Albumin/Creatinine analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes Albumin/Creatinine(mg/g).
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Change from baseline outcome measure at 10th week (post-test)
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Urine Nitrite (dipstick) analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes Nitrite(-/+).
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Change from baseline outcome measure at 10th week (post-test)
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Urine WBC esterase analysis
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Fasting for 8 hours, collecting 10ml urine.
Routine urine analysis which includes WBC esterase(-/+).
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Change from baseline outcome measure at 10th week (post-test)
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Superoxide dismutase (SOD) Oxidative stress assessment
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Oxidative stress assessment to assess Superoxide dismutase (SOD) in serum was measured by the ELISA kit.
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Change from baseline outcome measure at 10th week (post-test)
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Glutathione peroxidase (GPx) Oxidative stress assessment
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Oxidative stress assessment to assess Glutathione peroxidase (GPx) in serum was measured by the ELISA kit..
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Change from baseline outcome measure at 10th week (post-test)
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Catalase Oxidative stress assessment
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Oxidative stress assessment to assess Catalase in serum was measured by the ELISA kit..
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Change from baseline outcome measure at 10th week (post-test)
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Physical examination-Height
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure participants' height.
The height measurement method is to measure after you take off your shoes and step on the machine.
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Change from baseline outcome measure at 10th week (post-test)
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Physical examination- Body weight
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure participants' body weight.
The body weight measurement method is to measure after you take off your shoes and step on the weight machine.
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Change from baseline outcome measure at 10th week (post-test)
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Physical examination - waist circumference
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure participants' waist circumference.
The waist measurement method is to use a tape measure to measure the waist circumference above the human hips.
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Change from baseline outcome measure at 10th week (post-test)
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Physical examination - arm circumference
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure participants' arm circumference.
The measurement method of the arm circumference is the circumference of the upper arm and is measured at the mid-point between the tips of the shoulder and elbow. .
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Change from baseline outcome measure at 10th week (post-test)
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Physical examination - calf circumference
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure participants' calf circumference.
The measurement method of the calf circumference should be the same as the shoulder width and place the tape measure at the thickest part of the calf with a horizontal line around it for measurement.
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Change from baseline outcome measure at 10th week (post-test)
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Physical examination - hip circumference
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Measure participants' hip circumference.
The hip measurement method is to use a tape measure to measure the maximum hip diameter.
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Change from baseline outcome measure at 10th week (post-test)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical Activity Questionnaire assessment
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
Using Physical Activity Questionnaire to assess participants' activity level.
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Change from baseline outcome measure at 10th week (post-test)
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24-hour Dietary Recall Form
時間枠：Change from baseline outcome measure at 10th week (post-test)
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The 24-hour diet recall method is conducted by interviewers who have received professional training in food serving size.
Ask participants to recall all food and beverages actually consumed in the past 24 hours and record them in the questionnaire.
Location, and the name, material, quantity and preparation method of food; among them, the estimation of the quantity can be assisted by using food weighing tools and food quantitative aids.
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Change from baseline outcome measure at 10th week (post-test)
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Gastrointestinal Function Assessment
時間枠：Change from baseline outcome measure at 10th week (post-test)
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Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence
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Change from baseline outcome measure at 10th week (post-test)
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Mini nutrition assessment
時間枠：Change from baseline outcome measure at 10th week (post-test)
|
This Mini nutrition assessment is a Indicator of nutrition status .The score range from 0-30,24 to 30 points represent Normal nutritional status, 17 to 23.5 points represent At the risk of malnutrition, less than 17 points represent Malnourished.
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Change from baseline outcome measure at 10th week (post-test)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Hui-Yu Huang, Ph.D、Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年10月12日
一次修了 (実際)
2020年6月30日
研究の完了 (実際)
2020年6月30日
試験登録日
最初に提出
2019年4月15日
QC基準を満たした最初の提出物
2021年6月27日
最初の投稿 (実際)
2021年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月7日
QC基準を満たした最後の更新が送信されました
2021年6月27日
最終確認日
2021年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。