Safe and Secure Gluten Free Diet

March 2, 2026 updated by: Arrate Lasa, University of the Basque Country (UPV/EHU)

Dieta Sin Gluten Equilibrada y Segura: Estudio De Biomarcadores y De Los Factores Determinantes Para Alcanzar El Equilibrio Nutricional y La Ausencia de Síntomas

The only treatment for celiac disease (CD) consists of following a strict lifelong gluten-free diet, which may lead to potential dietary imbalances and associated diseases. Although individualized dietary counseling should be mandatory for people with celiac disease, they often do not receive this information, and there are few specific biomarkers that provide information about their progression and nutritional status.

Moreover, in the classic form of CD, gastrointestinal symptoms caused by gluten ingestion predominate. One might assume that removing this protein from the diet would lead to the complete remission of these symptoms; however, it has been shown that this is not always the case. Therefore, research into other possible dietary triggers of persistent symptoms is of great interest (including FODMAPs, ATIs, or histamine).

On the other hand, individuals within the celiac and gluten-sensitive (C-GS) community sometimes feel misunderstood by society, which makes greater education necessary both for this group and for their surroundings (the general population) to ensure their full social inclusion.

This project aims to improve the quality of life of people with C-GS by acting within the healthcare setting through dietary intervention and nutritional education; from a scientific perspective, by investigating possible causes of their symptoms and identifying biomarkers to help monitor their treatment and progression; and from a social perspective, by promoting knowledge about CD and the gluten-free diet among the general population. It also provides new technological tools for self-care and clinician-patient communication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

GENERAL AND SPECIFIC OBJECTIVES

The aim of this project is to improve the quality of life of people with celiac disease-gluten sensitivity (CD-GS) by studying factors that may determine the success of a gluten-free diet (GFD). To this end, the following general (G) and specific (E) objectives have been established:

G1. Improvement of software for nutritional assessment and safety of the gluten-free diet.

Since removing gluten from the diet is not an easy task and often leads to dietary imbalance and risk of unintentional consumption, the goal is to enhance the GlutenFreeDiet software by incorporating new features, a wider range of specific gluten-free foods, and a more appealing and intuitive graphic design. In addition, a tool will be developed to allow users to identify, measure, and provide data on the FODMAP, ATI, and histamine content of foods, facilitating progress in determining the relationship between these compounds and persistent symptoms in individuals with CD following a GFD.

Specific objectives under G1:

E1. Improvement and adaptation of the software with new functionalities.

E2. Quantification of FODMAPs, ATIs, and histamine content in both conventional foods and foods specifically produced for people with celiac disease, followed by updating the software database with experimental or literature-based data.

E3. Determination of FODMAP, ATI, and histamine intake among the pediatric and adolescent CD-GS population in the Basque Autonomous Community (CAPV).

G2. Promotion of a healthy nutritional status in people with CD-GS. Eliminating gluten from the diet also removes key foods that are important sources of fiber and micronutrients, potentially leading to imbalances that affect health and even compromise growth in children. To improve dietary habits and prevent deficiencies and dietary transgressions, it is necessary to analyze how individuals adapt to their new diet and support them throughout this process by identifying errors, symptoms, intake of suspected triggering compounds, and measuring quality-of-life parameters. This will enable personalized counseling and education. Furthermore, characterizing and monitoring new non-invasive biomarkers that may be useful in the clinical management of GFD and related conditions is of great interest.

Specific objectives under G2:

E4. Assessment and monitoring of nutritional status, dietary habits, GFD adherence, symptoms, and quality of life in the pediatric and adolescent CD-GS population.

E5. Study of novel blood biomarkers that may help monitor disease progression during GFD treatment.

E6. Analysis of the relationship between symptoms and dietary habits, including the role of FODMAPs, ATIs, histamine (E2), and blood parameters (E5) in symptom persistence.

E7. Personalized dietary intervention and nutrition education to optimize participants' nutritional status.

G3. Expanding knowledge about CD-GS and the gluten-free diet in this population and in society at large.

Since socialization and safety in unfamiliar environments affect quality of life, education is necessary not only for the celiac community but also for their surroundings and society as a whole. Awareness will foster inclusion, reduce anxiety about accidental exposure, and improve mood and quality of life.

E8. Design and implementation of scientific outreach activities on gluten and celiac disease aimed at children and their families.

METHODOLOGY AND WORK PLAN

The objectives will be addressed through a series of tasks organized into three stages.

STAGE 1: IMPROVEMENT OF THE "GLUTENFREEDIET" SOFTWARE

Task 1. Software improvement and expansion (E1). Development of a digital solution to support healthcare professionals and enhance self-care for CD-GS individuals. This includes expanding the gluten-free product database, adding nutrition education features, improving visual design, enabling inclusion of homemade recipes, and expanding vegetarian options.

Task 2. Quantification of potentially harmful molecules (E2). Database expansion with literature and experimental data on ATIs, histamine, and FODMAPs. Analytical quantification will include fructans (via spectrophotometry) and other FODMAPs (ion chromatography). Thirty gluten-free cereal-based products will be analyzed. Histamine and ATIs will be measured using ELISA and enzymatic activity assays.

Task 3. Determination of intake of these compounds in the pediatric CD-GS population of the Basque Country (E3).

Dietary intake will be assessed using 24-hour recalls, and consumption of these compounds will be calculated.

Milestones:

Improved GlutenFreeDiet software

Determination of food content in FODMAPs, ATIs, histamine

Quantification of intake of potentially harmful molecules

STAGE 2: ASSESSMENT AND MONITORING OF NUTRITIONAL STATUS AND DIETARY HABITS

Conducted with six pediatric gastroenterology units. Recently diagnosed patients (3-14 years) will be followed at diagnosis (VT0), 3 months (VT3), and 12 months (VT12).

Task 4 (E4): Nutritional, dietary, symptom, and quality-of-life assessments. Task 5 (E5): Blood and urine biomarker analysis (microRNAs, citrulline, platelet volume, antioxidant capacity, membrane lipidomics, GIPs in urine, etc.).

Task 6 (E6): Relationship between symptoms, dietary compounds, and biomarkers. Task 7 (E7): Personalized dietary intervention and education (sessions at month 1, 4, and 13).

Milestones:

4. Improved nutritional status and habits 5. Definition of biomarkers 6. Role of FODMAPs, ATIs, histamine in symptoms

STAGE 3: INCREASING SOCIETAL AWARENESS

Task 8 (E8): Outreach workshops in schools and family settings, gluten detection activities, labeling education, sensory analysis of gluten-free foods, and balanced GFD design. Activities will also be disseminated through social media and the GLUTEN3S research group website.

Milestone 7: Increased societal knowledge of CD and the GFD through educational outreach.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria-Gasteiz, Alava, Spain, 01006
        • Arrate Lasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a child who volunteered to participate in the intervention study.
  • Being a child with a recent diagnosis of CD.
  • Being willing to follow a GFD.

Exclusion Criteria:

  • A history of chronic diseases (e.g., cardiovascular diseases, diabetes, hyperthyroidism/hypothyroidism, hypercholesterolemia, hypertriglyceridemia, or hypertension) or other digestive pathologies requiring specific dietary advice.
  • Lacking a desire to be part of the intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary habits measurement
Time Frame: 1 year
The consumption of all foods of daily and weekly intake was measured after the intervention. the consumption of foods was measured as protions /day or portions/week.
1 year
Quality of life measurement
Time Frame: 1 year
A total score of quality of life as well as the score in three subscales (having celiac disease, Diet and communication were analyzed. The scales went from 1 (very poor queality of life) to 5 (very good quality of life) points.
1 year
Biomarkers analysis
Time Frame: 1 year
FABP and citrulline were measured in serum through ELISA method.
1 year
Serum protein and cytokine expression measurement
Time Frame: 1 year
92 serum proteins were analyzed using Proximity Extension Assay (PEA) technology, implemented through the Olink® Target 96 Inflammation panel.
1 year
miRNA analysis
Time Frame: 1 year
A library of 644 circulating miRNAs were measured. miRNA sequencing libraries were prepared using the Lexogen Small RNA-Seq Library Prep Kit.
1 year
Gluten Inmunogenic Peptides (GIP) quantification
Time Frame: 1 year
GIP presence in urine and stool was measured by ELISA techniques.
1 year
Gastrointestinal and Extra-intestinal sympthoms measurements
Time Frame: 1 year

The quantity and the intensity of gastro intestinal symptoms were measured with Gastrointestinal Symptom Rating Scale (GSGR) questionnaire. The GSGR questionnaire assesses 15 gastrointestinal and diet-related symptoms at different levels of intensity. When symptom burden is evaluated as the number of reported symptoms, the total score ranges from 0 to 15, with values close to 0 indicate absence of symptoms and values close to 15 all assessed symptoms. When symptom severity is considered, the total score ranges from 0 to 90, with values close to 0 indicating few symptoms at low intensity and values close to 90 many symptoms at high intensity.

Extra intestinal symptoms presence was measured with a questionnaire that was adapted from a questionnaire used to measure 12 of these sympthoms in Non Gluten Celiac Sensitivity, 0 indicates no sympthoms and 12 all of them.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

Osakidetza
Asociación de Celiacos y Sensibles al Gluten de Madrid
Asociación de Celiacos de Euskadi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID2021-125695OA-I00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We have not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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