Trial · NCT07909772
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Body Mass Index (BMI) at 6 Months | Baseline (T₀) and 6 months (T₆) | Body Mass Index (BMI) is calculated as weight in kilograms divided by height in meters squared (kg/m²). |
| Primary | Mean Change From Baseline in Waist Circumference at 6 Months | Baseline (T₀) and 6 months (T₆) | Waist circumference measured in centimeters (cm) to assess central adiposity. |
| Primary | Mean Change From Baseline in Hip Circumference at 6 Months | Baseline (T₀) and 6 months (T₆) | Hip circumference measured in centimeters (cm). |
| Primary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at 6 Months | Baseline (T₀) and 6 months (T₆) | Fasting plasma glucose levels are measured in milligrams per deciliter (mg/dL). |
| Primary | Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months | Baseline (T₀) and 6 months (T₆) | Glycated hemoglobin percentage is measured as a total proportion of hemoglobin (mmol/mol). |
| Primary | Mean Change From Baseline in Fasting Insulin Levels at 6 Months | Baseline (T₀) and 6 months (T₆) | Fasting serum insulin levels are measured in micromoles per milliliter (μIU/mL). |
| Primary | Mean Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index at 6 Months | Baseline (T₀) and 6 months (T₆) | The minimum possible score is 0, with no set maximum value. Higher scores indicate a worse outcome (greater insulin resistance). |
| Primary | Mean Change From Baseline in Total Cholesterol at 6 Months | Baseline (T₀) and 6 months (T₆) | Total serum cholesterol levels measured in milligrams per deciliter (mg/dL). |
| Primary | Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at 6 Months | Baseline (T₀) and 6 months (T₆) | High-density lipoprotein cholesterol levels measured in milligrams per deciliter (mg/dL). |
| Primary | Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at 6 Months | Baseline (T₀) and 6 months (T₆) | Low-density lipoprotein cholesterol levels measured in milligrams per deciliter (mg/dL). |
| Primary | Mean Change From Baseline in Triglycerides at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum triglyceride levels measured in milligrams per deciliter (mg/dL). |
| Primary | Mean Change From Baseline in Aspartate Aminotransferase (AST) Activity at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum aspartate aminotransferase enzymatic activity levels are measured in units per liter (U/L). |
| Primary | Mean Change From Baseline in Alanine Aminotransferase (ALT) Activity at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum alanine aminotransferase enzymatic activity levels were measured in units per liter (U/L). |
| Primary | Mean Change From Baseline in Gamma-Glutamyl Transferase (γ-GT) Activity at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum gamma-glutamyl transferase enzymatic activity levels were measured in units per liter (U/L). |
| Primary | Alpha Diversity (Shannon Index) | Baseline (T₀) and 6 months (T₆) | Alpha diversity of the gut microbiota assessed using the Shannon Index derived from 16S rRNA sequencing of fecal samples. The Shannon Index accounts for both abundance and evenness of the microbial species present. The scale ranges from a minimum value of 0 to a maximum value of approximately 5 or higher. Higher index values indicate a better outcome (greater gut microbiota diversity and evenness). |
| Primary | Change From Baseline in Gut Microbiota Alpha Diversity (Chao1 Index) at 6 Months | Baseline (T₀) and 6 months (T₆) | Alpha diversity of the gut microbiota was assessed using the Chao1 Index derived from 16S rRNA sequencing of fecal samples. The Chao1 index estimates total species richness. The index ranges from a minimum value of 0 with no defined maximum score. Higher index values indicate a better outcome (greater microbial species richness). |
| Secondary | Mean Change From Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Levels at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum concentrations of the inflammatory cytokine tumor necrosis factor-alpha (TNF-α), measured in picograms per milliliter (pg/mL). |
| Secondary | Mean Change From Baseline in Serum Interleukin-10 (IL-10) Levels at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum concentrations of the anti-inflammatory cytokine Interleukin-10 (IL-10), measured in picograms per milliliter (pg/mL) |
| Secondary | Mean Change From Baseline in Serum Interleukin-1 Beta (IL-1β) Levels at 6 Months | baseline (T₀) and 6 months (T₆) | Serum concentrations of the inflammatory cytokine Interleukin-1 Beta (IL-1β), measured in picograms per milliliter (pg/mL). |
| Secondary | Mean Change From Baseline in Serum Interleukin-6 (IL-6) Levels at 6 Months | Baseline (T₀) and 6 months (T₆) | Serum concentrations of the inflammatory cytokine Interleukin-6 (IL-6), measured in picograms per milliliter (pg/mL). |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07909772/registered