Trial · NCT07893301
The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
NCT07893301, Not applicable, Active not recruiting, Federico II University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters. Trials, record NCT07893301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
- NCT number
- NCT07893301
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 22 participants, actual
- Lead sponsor
- Federico II University
- Conditions
- Gastrointestinal Health
- Interventions
- Postbiotic Supplement, Placebo
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07893301
GET https://conductscience.org/api/trials/v1/NCT07893301/registered