Gluten Free Diet for Hashimoto's Disease

Overseen By Kimberly Jenkins, MSNM

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must be taking: Thyroid hormone

Disqualifiers: Thyroid surgery, Celiac disease, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a gluten-free diet can improve symptoms for people with Hashimoto's thyroiditis. Hashimoto's is an autoimmune condition that may cause brain fog, fatigue, and weight gain, even when thyroid hormone levels remain normal. The trial targets individuals already on thyroid hormone replacement who still experience a decline in quality of life. Participants should have a Hashimoto's diagnosis and find that their symptoms significantly impact daily life. Those who meet these criteria and have not recently followed a gluten-free diet may find this trial suitable. As an unphased trial, it offers a unique opportunity to investigate a potential dietary approach to enhancing quality of life.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves a gluten-free diet, you should discuss any medication changes with your doctor.

What prior data suggests that a gluten-free diet is safe for individuals with Hashimoto's disease?

Research has shown that a gluten-free diet might help people with Hashimoto's disease. Some studies have found that this diet can reduce certain thyroid antibodies, such as anti-Tg, which are linked to inflammation and symptoms. However, other research suggests it might increase another antibody, anti-TPO. Notably, no major side effects have been reported with a gluten-free diet, indicating it is generally safe for most people. Those considering this diet should consult a healthcare provider to ensure it is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

A gluten-free diet is unique for managing Hashimoto's disease because it approaches the condition through dietary changes rather than medication. Traditional treatments for Hashimoto's usually involve hormone replacement therapies, such as levothyroxine, which supplement the hormones that the thyroid gland can no longer produce effectively. Researchers are excited about the potential of a gluten-free diet because it may address underlying autoimmune triggers by eliminating gluten, a protein that some believe can exacerbate autoimmune responses. This approach is non-invasive and could potentially minimize the need for medication, offering a more natural way to manage symptoms and improve quality of life for those with Hashimoto's.

What evidence suggests that a gluten-free diet might be an effective treatment for Hashimoto's disease?

Research suggests that a gluten-free diet can benefit people with Hashimoto's disease. This trial will evaluate the effects of a gluten-free diet on individuals with Hashimoto's hypothyroidism. Studies have shown that avoiding gluten might help reduce inflammation and improve thyroid function. For instance, one study found that a gluten-free diet lowered thyroid antibodies, which are part of the immune response in Hashimoto's. Another study reported improved thyroid function when patients stopped eating gluten. While these findings are encouraging, some studies showed mixed results, such as changes in certain antibody levels. Overall, a gluten-free diet seems to help improve symptoms in people with Hashimoto's thyroiditis. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Hashimoto's thyroiditis, an autoimmune condition causing hypothyroidism. Participants should have persistent symptoms despite normal thyroid hormone levels on medication. They must not have conditions like celiac disease that could affect the response to a gluten-free diet.

Inclusion Criteria

Thyroid hormone levels (TSH, Free T4 and Free T3 as available) within the normal reference range within 3 months of the study initiation

Self-perception of reduced quality of life since diagnosis as determined by a ThyPRO score greater than or equal to 35

I have been diagnosed with Hashimoto's thyroiditis.

Exclusion Criteria

Pregnancy

Use of gluten-free diet within prior 6 months

Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a gluten-free diet to assess its impact on Hashimoto's thyroiditis symptoms

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gluten Free Diet

Trial Overview The study explores whether a gluten-free diet can reduce thyroid antibodies and inflammation in Hashimoto's patients, potentially improving quality of life without surgery or additional medications.

How Is the Trial Designed?

Group I: Gluten Free Diet in Hashimoto's Hypothyroidism Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9101474/

Doubtful Justification of the Gluten-Free Diet in the Course ... According to this study, following a gluten-free diet had a beneficial effect on the course of Hashimoto's disease. However, it is worth ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07060118

Gluten Free Diet in Hashimoto's Hypothyroidism Hence, elimination of gluten in diet may improve the autoimmunity and inflammation association with Hashimoto's thyroiditis, leading to improvement in negative ...

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1200372/full

Effect of gluten-free diet on autoimmune thyroiditis ... Our results seem to indicate a positive effect of the gluten deprivation on thyroid function and its inflammation, particularly in patients with HT and GRC.

4. mdpi.com mdpi.com/2072-6643/17/21/3437

Effects of Gluten-Free Diet in Non-Celiac Hashimoto's ... The most important findings in this meta-analysis were that GFD decreased the mean difference in anti-Tg and had the opposite effect on anti-TPO, increasing its ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/fsn3.3833

Evaluation of the effect of gluten‐free diet and ... A gluten-free diet reduces antibody concentration and regulates thyroid autoimmunization. Mediterranean diet reduces oxidative stress.

6. sciety-discovery.elifesciences.org sciety-discovery.elifesciences.org/articles/by?article_doi=10.20944/preprints202506.2146.v1

Effects of Gluten-Free Diet in Non-Celiac Hashimoto's Thyroiditis Conclusion: The GFD decreased Anti-Tg and increased the Anti-TPO levels, both significantly. There were no significant results on fT3, fT4, and ...

7. digitalcommons.gardner-webb.edu digitalcommons.gardner-webb.edu/pa-department-journal-of-medical-science/52/

"The Effects of a Gluten-Free Diet on Patients with ... Results: Two articles agree that a decrease in thyroid antibodies, anti-TPO and anti-TG, can occur with a gluten-free diet when a patient has both Hashimoto's ...