Koji Product Supplementation' s Study (KPS)
27 juni 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Taipei City, Taiwan, 110
- Taipei Medical University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body mass index
Tidsram: 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).
|
Change from baseline outcome measure at 10th week (post-test)
|
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Fat mass
Tidsram: 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 fat mass.
|
Change from baseline outcome measure at 10th week (post-test).
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Muscle mas
Tidsram: 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 and appendicular skeletal muscle mass.
|
Change from baseline outcome measure at 10th week (post-test)
|
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Visceral fat area(VFA)
Tidsram: 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 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)
Tidsram: 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 Basal Metabolic Rate(BMR) (kcal) . |
Change from baseline outcome measure at 10th week (post-test)
|
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whole body Mineral
Tidsram: 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 Mineral (kg) in whole body. . |
Change from baseline outcome measure at 10th week (post-test)
|
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Bone Mineral Content
Tidsram: 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 Bone Mineral Content (kg).
|
Change from baseline outcome measure at 10th week (post-test)
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Cellular Water
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography.
|
Change from baseline outcome measure at 10th week (post-test)
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Inflammatory Cytokines TNF-α Analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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).
|
Change from baseline outcome measure at 10th week (post-test)
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Inflammatory Cytokines IL-6 Analysis
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of MCH(pg).
|
Change from baseline outcome measure at 10th week (post-test)
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Platelets analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
|
Change from baseline outcome measure at 10th week (post-test)
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WBC analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of AST(U/L).
|
Change from baseline outcome measure at 10th week (post-test)
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ALT analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
|
Change from baseline outcome measure at 10th week (post-test)
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GGT analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
|
Change from baseline outcome measure at 10th week (post-test)
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T-Cholesterol analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL).
|
Change from baseline outcome measure at 10th week (post-test)
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Triglyceride analysis
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
|
Change from baseline outcome measure at 10th week (post-test)
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BUN analysis
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Measure participants' hip circumference.
The hip measurement method is to use a tape measure to measure the maximum hip diameter.
|
Change from baseline outcome measure at 10th week (post-test)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Physical Activity Questionnaire assessment
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Using Physical Activity Questionnaire to assess participants' activity level.
|
Change from baseline outcome measure at 10th week (post-test)
|
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24-hour Dietary Recall Form
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
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
Tidsram: Change from baseline outcome measure at 10th week (post-test)
|
Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence
|
Change from baseline outcome measure at 10th week (post-test)
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Mini nutrition assessment
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Hui-Yu Huang, Ph.D, Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 oktober 2018
Primärt slutförande (Faktisk)
30 juni 2020
Avslutad studie (Faktisk)
30 juni 2020
Studieregistreringsdatum
Först inskickad
15 april 2019
Först inskickad som uppfyllde QC-kriterierna
27 juni 2021
Första postat (Faktisk)
7 juli 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 juli 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juni 2021
Senast verifierad
1 juni 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201806058RINA
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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