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Trial · NCT07897981

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIntrahepatic lipid (IHL)Baseline, up to 60 days of the studyIHL content was assessed by MRI using a 3.0-T scanner
Secondaryalanine aminotransferase (ALT, U/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. AST was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Secondaryγ-glutamyltransferase (GGT, U/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. GGT was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Secondaryaspartate aminotransferase (AST, U/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. AST was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
SecondaryHemoglobin A1c (HbA1c, %)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. HbA1c was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
SecondaryFasting blood glucose (FBG, mmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. FBG was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Secondaryserum triglycerides (TG, mmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. TG was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Secondarytotal cholesterol (TC, mmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. TC was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Secondarylow-density lipoprotein cholesterol (LDL-C, mmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. LDL-C was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Secondaryhigh-density lipoprotein cholesterol (HDL-C, mmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. HDL-C was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
OtherTumor necrosis factor (TNF-α, pg/mL)Baseline, up to 60 days of the studySerum TNF-α was performed using a cytometric bead array (CBA) method with a commercially available human inflammatory cytokine kit (BD Biosciences, Heidelberg, Germany).
Otherinterleukins (IL-1β, pg/mL)Baseline, up to 60 days of the studySerum IL-1β was performed using a cytometric bead array (CBA) method with a commercially available human inflammatory cytokine kit (BD Biosciences, Heidelberg, Germany).
OtherBlood creatinine (CREA, μmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. CREA was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
Otherurea nitrogen (BUN, mmol/L)Baseline, up to 60 days of the study
Fasting blood samples were collected at baseline and week 12 after an overnight fast. Serum was separated from blood samples after centrifugation with 3,000 rpm at 4°C for 10 min, and immediately stored at -80°C until use. BUN was measured using an automated biochemical analyzer (HITACHI LABOSPECT 008, Sysmex, Kobe, Japan)
OtherIntestinal floraBaseline, up to 60 days of the study16s rRNA sequencing
Otherserum untargeted metabolomicsBaseline, up to 60 days of the studySerum untargeted metabolomics was performed using a Vanquish UHPLC system coupled to an Orbitrap Exploris 120 mass spectrometer (Thermo Fisher Scientific, USA)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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