Trial · NCT07898267
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Body Weight from Baseline at Week 12 | Baseline and Week 12 | Percentage change in body weight from baseline to Week 12, calculated as \[(body weight at Week 12 - body weight at baseline) / body weight at baseline\] × 100. The percentage change will be compared between the Akkermansia supplementation group and the placebo group. |
| Secondary | Change in Body Mass Index from Baseline | Baseline, Weeks 4, 8, 12, 18, and 24. | Change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared, from baseline to each follow-up visit. Results will be reported in kg/m². |
| Secondary | Change in Waist Circumference from Baseline | Baseline, Weeks 4, 8, 12, 18, and 24. | Change in waist circumference from baseline at each follow-up visit. Waist circumference will be measured using the standardized study procedure and reported in centimeters. |
| Secondary | Change in Body Fat Percentage from Baseline | Baseline, Weeks 12 and 24. | Change in body fat percentage from baseline, measured using the body composition assessment method specified in the study protocol. Results will be reported as percentage points. |
| Secondary | Change in Fasting Blood Glucose from Baseline | Baseline, Weeks 12 and 24. | Change in fasting blood glucose concentration from baseline. Blood samples will be collected after the fasting period specified in the study protocol. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in Glycated Hemoglobin from Baseline | Baseline, Weeks 12 and 24. | Change in glycated hemoglobin (HbA1c) from baseline. Results will be reported as a percentage or in mmol/mol, according to the laboratory method. |
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance from Baseline | Baseline, Weeks 12 and 24. | Change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline. HOMA-IR will be calculated using fasting glucose and fasting insulin according to the prespecified study method and reported as a dimensionless index. |
| Secondary | Change in Total Cholesterol from Baseline | Baseline, Weeks 12 and 24. | Change in serum total cholesterol concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in Triglyceride Concentration from Baseline | Baseline, Weeks 12 and 24. | Change in serum triglyceride concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in Low-Density Lipoprotein Cholesterol from Baseline | Baseline, Weeks 12 and 24. | Change in low-density lipoprotein cholesterol (LDL-C) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in High-Density Lipoprotein Cholesterol from Baseline | Baseline, Weeks 12 and 24. | Change in high-density lipoprotein cholesterol (HDL-C) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in Alanine Aminotransferase from Baseline | Baseline, Weeks 12 and 24. | Change in serum alanine aminotransferase (ALT) activity from baseline. Results will be reported in U/L. |
| Secondary | Change in Aspartate Aminotransferase Activity from Baseline | Baseline, Weeks 12 and 24. | Change in serum aspartate aminotransferase (AST) activity from baseline, calculated as the AST activity at the follow-up visit minus the AST activity at baseline. Results will be reported in units per liter (U/L). |
| Secondary | Change in Serum Creatinine from Baseline | Baseline, Weeks 12 and 24. | Change in serum creatinine concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in High-Sensitivity C-Reactive Protein from Baseline | Baseline, Weeks 12 and 24. | Change in high-sensitivity C-reactive protein (hs-CRP) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in Interleukin-1β Concentration from Baseline | Baseline, Weeks 12 and 24. | Change in interleukin-1β (IL-1β) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
| Secondary | Change in Relative Abundance of Akkermansia from Baseline | Baseline, Weeks 12 and 24. | Change in the relative abundance of Akkermansia in fecal samples from baseline, determined using the prespecified gut microbiota analysis method. Results will be reported as relative abundance using the same analytical method at each assessment. |
| Secondary | Changes in Fecal Gut Microbiota Composition Assessed by Microbiome Sequencing | Baseline, Weeks 12 and 24. | Changes from baseline in fecal gut microbiota composition assessed by microbiome sequencing. The analysis will characterize the relative abundance of bacterial taxa and identify differences in gut microbial composition between the Akkermansia supplementation group and the placebo group. Relative abundance will be reported for the prespecified microbial taxa using the same sequencing and bioinformatics procedures at each assessment. |
| Secondary | Change in Generalized Anxiety Disorder-7 Total Score from Baseline | Baseline, Weeks 12 and 24. | Change in the total score on the Generalized Anxiety Disorder-7 (GAD-7) questionnaire from baseline. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
| Secondary | Change in Patient Health Questionnaire-9 Total Score from Baseline | Baseline, Weeks 12 and 24. | Change in the total score on the Patient Health Questionnaire-9 (PHQ-9) from baseline. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. |
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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