Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
NCT07915063, Recruiting, Istituti Clinici Scientifici Maugeri SpA
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet | ClinicalTrials.gov |
| NCT number | NCT07915063 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA | ClinicalTrials.gov |
| Conditions | Celiac Disease, Gluten-free Diet, Gastrointestinal Symptoms | ClinicalTrials.gov |
| Interventions | Mediterranean Diet Adherence Evaluation, Highly Processed Food Consumption Evaluation | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score | Baseline (Single cross-sectional study visit, Day 1) | Severity of gastrointestinal symptoms over the past week, measured with the 10-item CeD-GSRS. Each item is rated on a 7-point Likert scale (1 = no discomfort at all; 7 = very severe discomfort). The score is the mean of the 10 items, ranging from 1 to 7, and higher scores indicate more severe symptoms. The score will be analysed in relation to Mediterranean diet adherence (PyrMDS) and highly processed food consumption (sQ-HPF), using correlation and multivariable linear regression. | ClinicalTrials.gov |
| Primary | Celiac Disease-Specific Quality of Life (CD-QOL) Score | Baseline (Single cross-sectional study visit, Day 1) | Coeliac disease-specific quality of life over the past 30 days, measured with the Italian validated 20-item CD-QOL. Items are rated on a 5-point Likert scale and the total score is transformed to a 0-100 scale, where higher scores indicate better quality of life. The score will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation and multivariable linear regression. | ClinicalTrials.gov |
| Primary | Pyramid-based Mediterranean Diet Score (PyrMDS) | Baseline (Single cross-sectional study visit, Day 1) | Adherence to the Mediterranean dietary pattern, measured with the 15-item PyrMDS. The score is continuous and ranges from 0 to 15, where higher scores indicate greater adherence. | ClinicalTrials.gov |
| Primary | Body Mass Index (BMI) | Baseline (Single cross-sectional study visit, Day 1) | BMI is calculated from measured weight and height (kg/m²). It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation and multivariable linear regression. | ClinicalTrials.gov |
| Secondary | Short Questionnaire of Highly Processed Food Consumption (sQ-HPF) Score | Baseline (Single cross-sectional study visit, Day 1) | Habitual consumption of highly processed foods, measured with the sQ-HPF. The score ranges from 0 to 14, where higher scores indicate greater consumption. | ClinicalTrials.gov |
| Secondary | Gluten-Free Diet Adherence (Biagi Score) | Baseline (Single cross-sectional study visit, Day 1) | Adherence to the gluten-free diet, measured with the Biagi score. The score ranges from 0 to 4, where higher scores indicate stricter adherence. | ClinicalTrials.gov |
| Secondary | Percentage of Participants with Persistent Gastrointestinal Symptoms | Baseline (Single cross-sectional study visit, Day 1) | The proportion of participants with persistent self-reported gastrointestinal symptoms. This proportion will be analysed in relation to PyrMDS and sQ-HPF scores using multivariable logistic regression. | ClinicalTrials.gov |
| Secondary | Waist Circumference | Baseline (Single cross-sectional study visit, Day 1) | Waist circumference (cm), measured according to standard procedures. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Secondary | Total Cholesterol | Baseline (Single cross-sectional study visit, Day 1) | Serum total cholesterol (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Secondary | LDL Cholesterol | Baseline (Single cross-sectional study visit, Day 1) | Serum LDL cholesterol (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Secondary | HDL Cholesterol | Baseline (Single cross-sectional study visit, Day 1) | Serum LDL cholesterol (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Secondary | Triglycerides | Baseline (Single cross-sectional study visit, Day 1) | Serum triglycerides (mg/dL) from routine blood tests. They will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Secondary | Fasting Glucose | Baseline (Single cross-sectional study visit, Day 1) | Fasting plasma glucose (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Hemoglobin | Baseline (Single cross-sectional study visit, Day 1) | Serum hemoglobin concentration (g/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Ferritin | Baseline (Single cross-sectional study visit, Day 1) | Serum ferritin concentration (ng/mL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Folate | Baseline (Single cross-sectional study visit, Day 1) | Serum folate concentration (ng/mL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Vitamin B12 | Baseline (Single cross-sectional study visit, Day 1) | Serum vitamin B12 concentration (pg/mL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Vitamin D (25-hydroxyvitamin D) | Baseline (Single cross-sectional study visit, Day 1) | Serum 25-hydroxyvitamin D concentration (ng/mL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Albumin | Baseline (Single cross-sectional study visit, Day 1) | Serum albumin concentration (g/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
| Other | Alanine Aminotransferase (ALT) | Baseline (Single cross-sectional study visit, Day 1) | Serum ALT (U/L) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)