Thyroid Autoimmune DiseaseTAILORNCT07879690
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
A study testing Gluten-free, casein-free, low-glycemic-index diet in people with Thyroid Autoimmune Disease and Hashimoto's Thyroiditis, run by University of Barcelona at 1 site in Andorra.
Trial summary
The purpose of this clinical trial is to evaluate whether a dietary intervention can improve clinical and immunological outcomes in women with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease. The study will enroll premenopausal women aged 18 to 55 years. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Thyroid Autoimmune Disease, Hashimoto's Thyroiditis, Graves Disease
- What is being tested?
- Gluten-free, casein-free, low-glycemic-index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAndorra
- Study dates
- Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 55 years, of reproductive age and not menopausal
- Confirmed diagnosis of autoimmune thyroiditis (Hashimoto's thyroiditis or Graves' disease) based on clinical, hormonal and immunological criteria
- Under clinical follow-up by an endocrinology unit
- Stable thyroid function; if on pharmacological treatment, stable for at least 3 months before study entry
- No relevant nutritional deficiencies (vitamin D, selenium, zinc, iron or vitamin B12), or adequately supplemented according to clinical criteria
- Willingness to participate in a supervised nutritional program and signed informed consent
Who cannot join
- Other active autoimmune or systemic diseases (e.g., lupus, multiple sclerosis, type 1 diabetes), active inflammatory bowel disease, peptic ulcer or intestinal infections
- Established menopause or perimenopause
- Body mass index outside the range 18.5-29.9 kg/m2
- Pregnancy or breastfeeding
- Use of immunosuppressive drugs or corticosteroids
- Previous restrictive diets
- Severe food intolerances or conditions preventing adherence to the protocol (e.g., wheat allergy, celiac disease, casein allergy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andorra1 site
Centre de Dietètica Laurence Lestang
Les Escaldes, Escaldes-Engordany, AD700
Laurence Lestang Doublet, MSc, RD, +376330583, llestang@student.universidadviu.com
laurencelestang.dietista@gmail.com
About this study
Official title: Impact of Restrictive Diets Targeting Inflammatory Dietary Components (Gluten, Casein, and High-glycemic-index Carbohydrates) on Inflammatory Markers and Quality of Life in Patients With Autoimmune Thyroiditis
The purpose of this clinical trial is to evaluate whether a dietary intervention can improve clinical and immunological outcomes in women with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease. The study will enroll premenopausal women aged 18 to 55 years.
The dietary intervention consists of the simultaneous exclusion of three groups of potentially pro-inflammatory dietary components:
Read more
- Gluten-containing cereals, including wheat, barley, and rye.
- Casein, the main protein found in milk and dairy products.
- High-glycemic-index carbohydrates, such as refined sugar, white bread, and white rice.
The primary objective is to determine whether the dietary intervention reduces serum levels of anti-thyroid peroxidase (anti-TPO) antibodies, which are markers of thyroid autoimmunity.
Secondary objectives include evaluating whether the intervention improves:
- Fatigue and energy levels.
- Mood and emotional well-being.
- Gastrointestinal symptoms.
- Health-related quality of life.
Women following the dietary intervention will be compared with women who continue their habitual diet to assess the effectiveness of the intervention. Group allocation will be based on participants' choice at study enrollment.
Participants will:
- Follow either the dietary intervention or their usual diet for 12 months while continuing their prescribed medical treatment.
- Attend four study visits: at baseline and after 4, 8, and 12 months.
- Undergo anthropometric assessments (body weight and waist circumference), blood sampling, stool collection, and a telemedicine consultation with a thyroid specialist at each visit.
- Complete brief online questionnaires every month to assess dietary adherence, fatigue, mood, gastrointestinal symptoms, and quality of life.
Read the detailed description
Background:
Previous studies have investigated the effects of gluten-free diets, casein-free diets, or the restriction of high-glycemic-index carbohydrates separately in individuals with autoimmune thyroid disease (AITD), yielding heterogeneous and inconclusive findings. The present study aims to evaluate the combined effect of simultaneously excluding these dietary components on immunological, clinical, and patient-reported outcomes in women with AITD. The dietary intervention is intended as a nutritional strategy under investigation and is not designed to replace standard medical treatment or routine clinical care.
Dietary Intervention:
Participants assigned to the intervention group will simultaneously eliminate gluten-containing cereals (wheat, barley, and rye), dairy-derived casein, and high-glycemic-index carbohydrates from the start of the study. No sequential elimination or reintroduction phases are planned. The study periods (months 0-4, 4-8, and 8-12) correspond exclusively to predefined assessment intervals. Apart from the dietary exclusions under investigation, participants will be advised to maintain a stable dietary pattern with comparable energy intake and macronutrient distribution throughout the study.
Group Allocation:
This is a prospective, non-randomized study. Group assignment will be determined at baseline, prior to initiation of the intervention, according to each participant's willingness and ability to follow the dietary protocol. To minimize potential selection bias associated with the absence of randomization, propensity score methods based on baseline characteristics, including age, body mass index (BMI), baseline anti-thyroid peroxidase antibody (anti-TPO) levels, thyroid-related treatment, and relevant lifestyle factors, will be incorporated into the statistical analysis through adjustment, stratification, or inverse probability of treatment weighting, as appropriate.
Adherence Assessment:
Adherence to the dietary protocol will be evaluated using a Nutritional Adherence Index calculated as: Adherence (%) = (days with complete compliance / total days evaluated) x 100. In the intervention group, satisfactory adherence will be defined as a compliance rate of at least 90%.
Sample Size Calculation:
The sample size is based on the primary outcome (change in anti-TPO antibody concentrations from baseline to month 12). In a comparable non-randomised trial of a gluten-free diet in women with Hashimoto's thyroiditis (Krysiak R, Szkróbka W, Okopień B. Exp Clin Endocrinol Diabetes. 2019;127(7):417-422. doi: 10.1055/a-0653-7108), the standard deviations of the 6-month change in anti-TPO were 105 and 25 U/mL (pooled SD approximately 74 U/mL), with a between-group difference of 229 U/mL. Assuming a pooled SD of 74 IU/mL, a two-sided alpha of 0.05 and 80% power, 24 evaluable participants per group allow detection of a between-group difference of about 60 IU/mL, approximately one quarter of the effect previously reported. Allowing for approximately 20% attrition, 30 participants per group will be recruited (total N = 60).
Statistical Analysis:
The primary analysis will evaluate changes in anti-TPO antibody concentrations between groups using multivariable regression models adjusted for potential confounding factors. Longitudinal changes across follow-up visits will be assessed using repeated-measures analysis of variance (ANOVA) or linear mixed-effects models, as appropriate. Both intention-to-treat and per-protocol analyses will be performed. Missing data will be addressed using multiple imputation methods.
Safety Monitoring:
Participants will be monitored throughout the study for potential adverse effects related to the dietary intervention. Predefined safety criteria include unintentional weight loss exceeding 5% of body weight within one month, clinically significant thyroid dysfunction requiring treatment adjustment, persistent gastrointestinal symptoms, evidence of nutritional deficiency, and significant psychological distress. Adverse events will be evaluated within 48 hours of notification, and serious adverse events will be reported to the relevant Ethics Committee within 7 calendar days, in accordance with applicable regulations.
- Being tested
- Gluten-free, casein-free, low-glycemic-index diet
- Keywords
- Dietary intervention, Gluten-free diet, Casein-free diet, High-glycemic-index carbohydrates, Low glycemic index diet, Inflammation, Immune modulation, Anti-TPO antibodies, Quality of life
- Medical subject headings
- Hashimoto Disease, Graves Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free, casein-free, low-glycemic-index dietOther
Participants in the intervention group will follow a dietary protocol consisting of the simultaneous exclusion of gluten-containing cereals (including wheat, barley, rye, spelt, and foods containing gluten), dairy products containing casein (including milk, yogurt, cheese, cream, butter, and related products), and high-glycemic-index carbohydrates (including refined sugar, refined grain products, white rice, and pastries). The dietary intervention will be maintained continuously for 12 months. No investigational medications, mandatory dietary supplements, or other therapeutic interventions will be administered as part of the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Triple-restriction diet | Experimental | Participants will follow a dietary protocol involving the simultaneous exclusion of gluten-containing cereals, dairy-derived casein, and high-glycemic-index carbohydrates from baseline through month 12. The intervention will be supported by individualized dietary guidance and monthly monitoring of adherence to the protocol. Receives: Other: Gluten-free, casein-free, low-glycemic-index diet |
| Usual diet | No intervention | Participants in the control group will continue their habitual diet without prescribed dietary modifications or restrictions. Dietary intake will be monitored using food frequency questionnaires and monthly dietary records. Participants will undergo the same follow-up schedule, clinical assessments, biological sample collection, and patient-reported outcome evaluations as the intervention group over the 12-month study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum anti-thyroid peroxidase (anti-TPO) antibody levels
Serum anti-TPO antibodies (IU/mL) measured by immunoassay in a fasting morning blood sample. Change from baseline to month 12 is compared between groups.
Measured: Baseline (month 0) and month 12
Secondary outcomes (14)
Change in serum anti-thyroglobulin (anti-Tg) antibody levels
Serum anti-Tg antibodies (IU/mL) measured by immunoassay.
Measured: Baseline, month 4, month 8 and month 12
Change in high-sensitivity C-reactive protein (hs-CRP)
Serum hs-CRP (mg/L) measured by immunoturbidimetry or nephelometry.
Measured: Baseline, month 4, month 8 and month 12
Change in erythrocyte sedimentation rate (ESR)
ESR (mm/h) measured by the Westergren method.
Measured: Baseline, month 4, month 8 and month 12
Change in fecal zonulin
Fecal zonulin measured by ELISA in a stool sample, as a marker of intestinal permeability.
Measured: Baseline, month 4, month 8 and month 12
Change in thyroid function (TSH, free T4 and free T3)
Serum TSH, free T4 and free T3 measured by immunoassay.
Measured: Baseline, month 4, month 8 and month 12
Change in micronutrient status (25-hydroxyvitamin D, ferritin and selenium)
Serum 25-hydroxyvitamin D, ferritin and selenium.
Measured: Baseline, month 4, month 8 and month 12
Change in fatigue (Fatigue Severity Scale)
FSS: 9 items scored 1 to 7; total score is the mean of items (range 1-7). Higher scores indicate more fatigue.
Measured: Monthly from baseline to month 12
Change in anxiety and depression (Hospital Anxiety and Depression Scale)
HADS: 14 items; anxiety and depression subscales each range 0-21. Higher scores indicate worse symptoms.
Measured: Monthly from baseline to month 12
Change in health-related quality of life (WHOQOL-BREF)
WHOQOL-BREF: 26 items across physical, psychological, social and environmental domains. Higher scores indicate better quality of life.
Measured: Monthly from baseline to month 12
Change in gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
GSRS: 15 items scored 1 to 7 across 5 symptom dimensions. Higher scores indicate worse symptoms.
Measured: Monthly from baseline to month 12
Change in weight
Weight (kg) measured with standard anthropometric techniques.
Measured: Monthly from baseline to month 12
Change in body mass index
Weight and height, measured with standard anthropometric techniques, will be combined to report Body Mass Index in kg/m^2 .
Measured: Monthly from baseline to month 12
Change in waist circumference
Waist circumference (cm) measured with standard anthropometric techniques.
Measured: Monthly from baseline to month 12
Dietary adherence (Nutritional Adherence Index)
Percentage of days with full compliance with the assigned diet, calculated from monthly dietary records.
Measured: Monthly from baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startJan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid Autoimmune DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, parallel-group study with non-randomized allocation. Group assignment is determined at baseline, prior to initiation of the intervention, according to each participant's willingness to adhere to the triple-restriction dietary protocol. To reduce potential selection bias and control for baseline imbalances between groups, propensity score methods based on relevant baseline characteristics will be incorporated into the statistical analysis.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Internacional de Valencia
- Responsible party
- Principal investigator, Natalia Toro Funes, University of Barcelona
- Investigators
- Laurence Lestang Doublet, MSc, RD, Principal investigator, Universidad Internacional de ValenciaNatalia Toro Funes, PhD, Principal investigator, Universidad de BarcelonaMariana Silva López, PhD, Study director, Universidad Internacional de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879690
- Sponsor's protocol ID
- CEIDTDM2026_01
- Acronym
- TAILOR
- Status last verified
- Nov 2026
- First submitted
- 6 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data are pseudonymized during the study and irreversibly anonymized after publication; results will be reported in aggregate form only, in accordance with the informed consent and applicable data protection regulations (GDPR and Andorran Law 29/2021).
Publications
Huang XS, Dai N, Xu JX, Xiang JY, Zheng XZ, Ke TY, Ma LY, Shi QH, Fan SF. MRI quantitative assessment of the effects of low-carbohydrate therapy on Hashimoto's thyroiditis. Endocr Connect. 2024 Apr 22;13(5):e230477. doi: 10.1530/EC-23-0477. Print 2024 May 1.
PubMed 38552311Aslan ES, Meral G, Aydin E, Caglayan S, Altundag A, Demirkol S, Gormus G, Solak M, Ayaz F. The Effect of a Casein and Gluten-Free Diet on the Epigenetic Characteristics of FoxP3 in Patients With Hashimoto's Thyroiditis. Cureus. 2024 Jun 26;16(6):e63208. doi: 10.7759/cureus.63208. eCollection 2024 Jun.
PubMed 38952602Ulker MT, Colak GA, Bas M, Erdem MG. Evaluation of the effect of gluten-free diet and Mediterranean diet on autoimmune system in patients with Hashimoto's thyroiditis. Food Sci Nutr. 2023 Nov 20;12(2):1180-1188. doi: 10.1002/fsn3.3833. eCollection 2024 Feb.
PubMed 38370054Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
PubMed 30060266
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Restrictive Diets Targeting Inflammatory Dietary Components (Gluten, Casein, and High-glycemic-index Carbohydrates) on Inflammatory Markers and Quality of Life in Patients With Autoimmune Thyroiditis
- ClinicalTrials.gov ID
- NCT07879690
- Acronym / sponsor ID
- TAILOR / CEIDTDM2026_01
- Keywords
- Dietary intervention, Gluten-free diet, Casein-free diet, High-glycemic-index carbohydrates, Low glycemic index diet, Inflammation, Immune modulation, Anti-TPO antibodies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Universidad Internacional de Valencia
- Study start
- Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate whether a dietary intervention can improve clinical and immunological outcomes in women with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease. The study will enroll premenopausal women aged 18 to 55 years.
The dietary intervention consists of the simultaneous exclusion of three groups of potentially pro-inflammatory dietary components:
- Gluten-containing cereals, including wheat, barley, and rye.
- Casein, the main protein found in milk and dairy products.
- High-glycemic-index carbohydrates, such as refined sugar, white bread, and white rice.
The primary objective is to determine whether the dietary intervention reduces serum levels of anti-thyroid peroxidase (anti-TPO) antibodies, which are markers of thyroid autoimmunity.
Secondary objectives include evaluating whether the intervention improves:
- Fatigue and energy levels.
- Mood and emotional well-being.
- Gastrointestinal symptoms.
- Health-related quality of life.
Women following the dietary intervention will be compared with women who continue their habitual diet to assess the effectiveness of the intervention. Group allocation will be based on participants' choice at study enrollment.
Participants will:
- Follow either the dietary intervention or their usual diet for 12 months while continuing their prescribed medical treatment.
- Attend four study visits: at baseline and after 4, 8, and 12 months.
- Undergo anthropometric assessments (body weight and waist circumference), blood sampling, stool collection, and a telemedicine consultation with a thyroid specialist at each visit.
- Complete brief online questionnaires every month to assess dietary adherence, fatigue, mood, gastrointestinal symptoms, and quality of life.
Detailed description
Background:
Previous studies have investigated the effects of gluten-free diets, casein-free diets, or the restriction of high-glycemic-index carbohydrates separately in individuals with autoimmune thyroid disease (AITD), yielding heterogeneous and inconclusive findings. The present study aims to evaluate the combined effect of simultaneously excluding these dietary components on immunological, clinical, and patient-reported outcomes in women with AITD. The dietary intervention is intended as a nutritional strategy under investigation and is not designed to replace standard medical treatment or routine clinical care.
Dietary Intervention:
Participants assigned to the intervention group will simultaneously eliminate gluten-containing cereals (wheat, barley, and rye), dairy-derived casein, and high-glycemic-index carbohydrates from the start of the study. No sequential elimination or reintroduction phases are planned. The study periods (months 0-4, 4-8, and 8-12) correspond exclusively to predefined assessment intervals. Apart from the dietary exclusions under investigation, participants will be advised to maintain a stable dietary pattern with comparable energy intake and macronutrient distribution throughout the study.
Group Allocation:
This is a prospective, non-randomized study. Group assignment will be determined at baseline, prior to initiation of the intervention, according to each participant's willingness and ability to follow the dietary protocol. To minimize potential selection bias associated with the absence of randomization, propensity score methods based on baseline characteristics, including age, body mass index (BMI), baseline anti-thyroid peroxidase antibody (anti-TPO) levels, thyroid-related treatment, and relevant lifestyle factors, will be incorporated into the statistical analysis through adjustment, stratification, or inverse probability of treatment weighting, as appropriate.
Adherence Assessment:
Adherence to the dietary protocol will be evaluated using a Nutritional Adherence Index calculated as: Adherence (%) = (days with complete compliance / total days evaluated) x 100. In the intervention group, satisfactory adherence will be defined as a compliance rate of at least 90%.
Sample Size Calculation:
The sample size is based on the primary outcome (change in anti-TPO antibody concentrations from baseline to month 12). In a comparable non-randomised trial of a gluten-free diet in women with Hashimoto's thyroiditis (Krysiak R, Szkróbka W, Okopień B. Exp Clin Endocrinol Diabetes. 2019;127(7):417-422. doi: 10.1055/a-0653-7108), the standard deviations of the 6-month change in anti-TPO were 105 and 25 U/mL (pooled SD approximately 74 U/mL), with a between-group difference of 229 U/mL. Assuming a pooled SD of 74 IU/mL, a two-sided alpha of 0.05 and 80% power, 24 evaluable participants per group allow detection of a between-group difference of about 60 IU/mL, approximately one quarter of the effect previously reported. Allowing for approximately 20% attrition, 30 participants per group will be recruited (total N = 60).
Statistical Analysis:
The primary analysis will evaluate changes in anti-TPO antibody concentrations between groups using multivariable regression models adjusted for potential confounding factors. Longitudinal changes across follow-up visits will be assessed using repeated-measures analysis of variance (ANOVA) or linear mixed-effects models, as appropriate. Both intention-to-treat and per-protocol analyses will be performed. Missing data will be addressed using multiple imputation methods.
Safety Monitoring:
Participants will be monitored throughout the study for potential adverse effects related to the dietary intervention. Predefined safety criteria include unintentional weight loss exceeding 5% of body weight within one month, clinically significant thyroid dysfunction requiring treatment adjustment, persistent gastrointestinal symptoms, evidence of nutritional deficiency, and significant psychological distress. Adverse events will be evaluated within 48 hours of notification, and serious adverse events will be reported to the relevant Ethics Committee within 7 calendar days, in accordance with applicable regulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, controlled, parallel-group study with non-randomized allocation. Group assignment is determined at baseline, prior to initiation of the intervention, according to each participant's willingness to adhere to the triple-restriction dietary protocol. To reduce potential selection bias and control for baseline imbalances between groups, propensity score methods based on relevant baseline characteristics will be incorporated into the statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| Triple-restriction diet | Experimental | Other: Gluten-free, casein-free, low-glycemic-index dietParticipants will follow a dietary protocol involving the simultaneous exclusion of gluten-containing cereals, dairy-derived casein, and high-glycemic-index carbohydrates from baseline through month 12. The intervention will be supported by individualized dietary guidance and monthly monitoring of adherence to the protocol. |
| Usual diet | No intervention | –Participants in the control group will continue their habitual diet without prescribed dietary modifications or restrictions. Dietary intake will be monitored using food frequency questionnaires and monthly dietary records. Participants will undergo the same follow-up schedule, clinical assessments, biological sample collection, and patient-reported outcome evaluations as the intervention group over the 12-month study period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 55 years, of reproductive age and not menopausal
- Confirmed diagnosis of autoimmune thyroiditis (Hashimoto's thyroiditis or Graves' disease) based on clinical, hormonal and immunological criteria
- Under clinical follow-up by an endocrinology unit
- Stable thyroid function; if on pharmacological treatment, stable for at least 3 months before study entry
- No relevant nutritional deficiencies (vitamin D, selenium, zinc, iron or vitamin B12), or adequately supplemented according to clinical criteria
Key exclusion criteria (7 listed)
- Other active autoimmune or systemic diseases (e.g., lupus, multiple sclerosis, type 1 diabetes), active inflammatory bowel disease, peptic ulcer or intestinal infections
- Established menopause or perimenopause
- Body mass index outside the range 18.5-29.9 kg/m2
- Pregnancy or breastfeeding
- Use of immunosuppressive drugs or corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten-free, casein-free, low-glycemic-index dietParticipants in the intervention group will follow a dietary protocol consisting of the simultaneous exclusion of gluten-containing cereals (including wheat, barley, rye, spelt, and foods containing gluten), dairy products containing casein (including milk, yogurt, cheese, cream, butter, and related products), and high-glycemic-index carbohydrates (including refined sugar, refined grain products, white rice, and pastries). The dietary intervention will be maintained continuously for 12 months. No investigational medications, mandatory dietary supplements, or other therapeutic interventions will be administered as part of the study protocol. | Other | Triple-restriction diet |
Primary outcome
Change in serum anti-thyroid peroxidase (anti-TPO) antibody levels
Time frame: Baseline (month 0) and month 12
Serum anti-TPO antibodies (IU/mL) measured by immunoassay in a fasting morning blood sample. Change from baseline to month 12 is compared between groups.
14 secondary outcomes
Change in serum anti-thyroglobulin (anti-Tg) antibody levels
Time frame: Baseline, month 4, month 8 and month 12
Change in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, month 4, month 8 and month 12
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline, month 4, month 8 and month 12
Change in fecal zonulin
Time frame: Baseline, month 4, month 8 and month 12
Change in thyroid function (TSH, free T4 and free T3)
Time frame: Baseline, month 4, month 8 and month 12
Change in micronutrient status (25-hydroxyvitamin D, ferritin and selenium)
Time frame: Baseline, month 4, month 8 and month 12
Change in fatigue (Fatigue Severity Scale)
Time frame: Monthly from baseline to month 12
Change in anxiety and depression (Hospital Anxiety and Depression Scale)
Time frame: Monthly from baseline to month 12
Change in health-related quality of life (WHOQOL-BREF)
Time frame: Monthly from baseline to month 12
Change in gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Time frame: Monthly from baseline to month 12
Change in weight
Time frame: Monthly from baseline to month 12
Change in body mass index
Time frame: Monthly from baseline to month 12
Change in waist circumference
Time frame: Monthly from baseline to month 12
Dietary adherence (Nutritional Adherence Index)
Time frame: Monthly from baseline to month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 38552311Huang XS, Dai N, Xu JX, Xiang JY, Zheng XZ, Ke TY, Ma LY, Shi QH, Fan SF. MRI quantitative assessment of the effects of low-carbohydrate therapy on Hashimoto's thyroiditis. Endocr Connect. 2024 Apr 22;13(5):e230477. doi: 10.1530/EC-23-0477. Print 2024 May 1.
- Background: PubMed 38952602Aslan ES, Meral G, Aydin E, Caglayan S, Altundag A, Demirkol S, Gormus G, Solak M, Ayaz F. The Effect of a Casein and Gluten-Free Diet on the Epigenetic Characteristics of FoxP3 in Patients With Hashimoto's Thyroiditis. Cureus. 2024 Jun 26;16(6):e63208. doi: 10.7759/cureus.63208. eCollection 2024 Jun.
- Background: PubMed 38370054Ulker MT, Colak GA, Bas M, Erdem MG. Evaluation of the effect of gluten-free diet and Mediterranean diet on autoimmune system in patients with Hashimoto's thyroiditis. Food Sci Nutr. 2023 Nov 20;12(2):1180-1188. doi: 10.1002/fsn3.3833. eCollection 2024 Feb.
- Background: PubMed 30060266Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data are pseudonymized during the study and irreversibly anonymized after publication; results will be reported in aggregate form only, in accordance with the informed consent and applicable data protection regulations (GDPR and Andorran Law 29/2021).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurence Lestang Doublet, MSc, RD principal investigator
Universidad Internacional de Valencia
Natalia Toro Funes, PhD principal investigator
Universidad de Barcelona
Mariana Silva López, PhD study director
Universidad Internacional de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free, casein-free, low-glycemic-index diet in people with Thyroid Autoimmune Disease and Hashimoto's Thyroiditis, run by University of Barcelona at 1 site in Andorra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Andorra. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence Lestang Doublet, MSc, RD (+376330583, llestang@student.universidadviu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum anti-thyroid peroxidase (anti-TPO) antibody levels (time frame: Baseline (month 0) and month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879690, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.