Trial · NCT07893301
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Gastrointestinal Symptom Rating Scale (GSRS) Score | Baseline (T0) and Week 12 (T1) | The Gastrointestinal Symptom Rating Scale (GSRS) is a validated 15-item questionnaire assessing five gastrointestinal symptom domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is scored on a 7-point Likert scale (1 = no symptoms; 7 = very severe symptoms), with higher scores indicating greater symptom severity. Changes in gastrointestinal symptoms are assessed from baseline (T0) to week 12 (T1). |
| Secondary | Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score | Baseline (T0) and Week 12 (T1) | Change in gastrointestinal-related quality of life assessed using the 36-item Gastrointestinal Quality of Life Index (GIQLI). Total scores range from 0 to 144, with higher scores indicating better quality of life. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Global Score | Baseline (T0) and Week 12 (T1) | Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
| Secondary | Change in Dietary Intake and Ultra-Processed Foods Consumption | Baseline (T0) and Week 12 (T1) | Dietary intake was assessed using 7-day food diaries collected at baseline and week 12. Nutritional analysis includes daily energy and macronutrient intake, the percentage of total energy intake derived from ultra-processed foods (UPFs) according to the NOVA classification, and estimated dietary advanced glycation end product (AGE) intake. |
| Secondary | Change in Body Composition Assessed by Bioelectrical Impedance Analysis | Baseline (T0) and Week 12 (T1) | Body composition was assessed at baseline and week 12 using phase-sensitive bioelectrical impedance analysis (BIA 101, Akern). Measurements include fat mass, fat-free mass, phase angle, and body water compartments. Anthropometric parameters, including body weight and body mass index (BMI), were also evaluated. |
| Secondary | Change in Skin Autofluorescence (SAF) | Baseline (T0) and Week 12 (T1) | Skin autofluorescence (SAF), a non-invasive marker of tissue advanced glycation end product (AGE) accumulation, was measured using the AGE Reader (DiagnOptics Technologies). Measurements were performed at baseline and after 12 weeks of supplementation. |
| Secondary | Change in Gut Microbiome Composition and Function | Baseline (T0) and Week 12 (T1) | Fecal samples collected at baseline and week 12 will undergo shotgun metagenomic sequencing to characterize gut microbial composition and functional potential. Metabolomic analyses will be performed to evaluate changes in microbial metabolites, including short-chain fatty acids such as acetate, propionate, and butyrate, following postbiotic supplementation. |
| Secondary | Change in Blood Biochemical Profile | Baseline (T0) and Week 12 (T1) | Changes in fasting blood biochemical parameters, including glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides, will be assessed at baseline and after 12 weeks of supplementation using automated enzymatic laboratory methods (mg/dL). |
| Secondary | Change in Fasting Insulin Levels | Baseline (T0) and Week 12 (T1) | Fasting insulin concentrations will be determined using a high-sensitivity enzyme-linked immunosorbent assay (ELISA) (µIU/mL). Changes will be assessed between baseline and Week 12. |
| Secondary | Change in Testosterone Levels | Baseline (T0) and Week 12 (T1) | Circulating testosterone concentrations will be assessed at baseline and after 12 weeks of supplementation (ng/dL). |
| Secondary | Change in Estradiol Levels | Baseline (T0) and Week 12 (T1) | Circulating estradiol concentrations will be assessed at baseline and after 12 weeks of supplementation (pg/mL). |
| Secondary | Change in Sex Hormone-Binding Globulin (SHBG) Levels | Baseline (T0) and Week 12 (T1) | Circulating sex hormone-binding globulin concentrations will be assessed at baseline and after 12 weeks of supplementation (nmol/L). |
| Secondary | Change in Inflammatory Cytokine Profile | Baseline (T0) and Week 12 (T1) | Changes in circulating inflammatory cytokines, including IL-2, IL-4, IL-6, IL-8, IL-10, IL-1β, TNF-α, and IFN-γ, will be assessed at baseline and after 12 weeks of supplementation using multiplex Luminex immunoassays (pg/mL). |
| Secondary | Change in Incretin Profile | Baseline (T0) and Week 12 (T1) | Changes in circulating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) concentrations will be assessed at baseline and after 12 weeks of supplementation using specific enzyme-linked immunosorbent assays (ELISA). |
| Secondary | Change in Serum Zonulin Levels | Baseline (T0) and Week 12 (T1) | Serum zonulin concentrations will be assessed at baseline and after 12 weeks of supplementation using an enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Change in Soluble Receptor for Advanced Glycation End Products (sRAGE) Levels | Baseline (T0) and Week 12 (T1) | Plasma soluble receptor for advanced glycation end products (sRAGE) concentrations will be assessed at baseline and after 12 weeks of supplementation using an enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Change in Plasma N-Acylethanolamine Profile | Baseline (T0) and Week 12 (T1) | Changes in circulating N-acylethanolamines, including anandamide (AEA), oleoylethanolamide (OEA), and palmitoylethanolamide (PEA), will be assessed at baseline and after 12 weeks of supplementation using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). |
| Secondary | Change in Epigenetic Age Ratio | Baseline (T0) and Week 12 (T1) | Changes in the epigenetic age ratio (ER) comparing baseline (T0) and after 12 weeks of supplementation (T1), assessed through DNA methylation profiling using the Illumina Infinium MethylationEPIC array and the Horvath Skin \& Blood epigenetic clock. ER will be calculated as \[(epigenetic age - chronological age) / chronological age\] × 100 and expressed as a percentage (%). |
| Secondary | Change in PBMC Gene Expression | Baseline (T0) and Week 12 (T1) | Changes in gene expression related to cellular redox pathways in peripheral blood mononuclear cells (PBMCs), comparing baseline (T0) and after 12 weeks of supplementation (T1), assessed using reverse transcription quantitative polymerase chain reaction (RT-qPCR). |
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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