Trial · NCT07897097
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Visceral Adipose Tissue Area | Day 3 (T1) and Day 17 (T2) | Change in abdominal visceral adipose tissue area measured by CT, calculated as the value on Day 17 minus the value on Day 3, expressed in cm². |
| Secondary | Change in Subcutaneous Adipose Tissue Area | Day 3 (T1) and Day 17 (T2) | Change in abdominal subcutaneous adipose tissue (SAT) area measured by CT, calculated as SAT area on Day 17 minus SAT area on Day 3 (ΔSAT), expressed in cm² |
| Secondary | Change in Total Abdominal Adipose Tissue Area | Day 3 (T1) and Day 17 (T2) | Change in total abdominal adipose tissue (TAT) area measured by CT, calculated as TAT area on Day 17 minus TAT area on Day 3 (ΔTAT), expressed in cm² |
| Secondary | Change in Visceral-to-Subcutaneous Adipose Tissue Ratio | Day 3 (T1) and Day 17 (T2) | Change in the ratio of visceral to subcutaneous adipose tissue area (VAT/SAT), calculated as the ratio on Day 17 minus the ratio on Day 3 |
| Secondary | Changes in Gut Microbial Alpha Diversity (Shannon Index) | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in fecal gut microbial alpha diversity measured by the Shannon diversity index using 16S rRNA gene sequencing. Shannon index values reflect microbial richness and evenness and are unitless. |
| Secondary | Changes in Gut Microbial Beta Diversity (Bray-Curtis Dissimilarity) | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in gut microbial community composition assessed using Bray-Curtis dissimilarity based on 16S rRNA gene sequencing data. Between-sample differences will be evaluated using PERMANOVA. |
| Secondary | Changes in Gut Microbial Taxonomic Abundance | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in the relative abundance of gut microbial taxa assessed by fecal microbiome sequencing and differential abundance analysis |
| Secondary | Changes in Fecal Short-Chain Fatty Acid Concentrations | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in fecal short-chain fatty acid concentrations, including acetate, propionate, and butyrate, assessed using metabolomic methods. |
| Secondary | Changes in High-Sensitivity C-Reactive Protein Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma hs-CRP concentrations measured across the study time points. |
| Secondary | Changes in Interleukin-6 Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma IL-6 concentrations measured across the study time points. |
| Secondary | Changes in Interleukin-10 Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma IL-10 concentrations measured across the study time points. |
| Secondary | Changes in Interleukin-18 Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma IL-18 concentrations measured across the study time points. |
| Secondary | Changes in Tumor Necrosis Factor-alpha Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma TNF-α concentrations measured across the study time points. |
| Secondary | Changes in Interleukin-1 Beta Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma IL-1β concentrations measured across the study time points. |
| Secondary | Changes in Monocyte Chemoattractant Protein-1 Levels | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in serum or plasma MCP-1/CCL2 concentrations measured across the study time points. |
| Secondary | Changes in Adipose Tissue UCP1 mRNA Expression | Day 3 (T1) and Day 17 (T2) | Changes in relative UCP1 mRNA expression in adipose tissue biopsies measured by RT-qPCR between Day 3 and Day 17. |
| Secondary | Changes in Adipose Tissue UCP1 Protein Expression | Day 3 (T1) and Day 17 (T2) | Changes in relative UCP1 protein expression in adipose tissue biopsies measured by Western blot between Day 3 and Day 17. |
| Secondary | Changes in Total Body Fat Mass | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in total body fat mass measured by dual-energy X-ray absorptiometry (DEXA), expressed in kg. |
| Secondary | Changes in Lean Body Mass | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in lean body mass measured by DEXA, expressed in kg. |
| Secondary | Changes in Body Fat Percentage | 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2) | Changes in body fat percentage measured by DEXA, expressed as a percentage. |
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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