Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis (METHAP)

University of Crete

Status: Active, not recruiting

Conditions: Psoriasis; Hashimoto Disease

Treatments: Combination Product: Nutraceutical Combination Plan

Study type: Interventional

Funder types: Other

Identifiers

NCT04693936

147/26.06.2020

Details and patient eligibility

About

Hashimoto's disease (HT) and psoriasis (PsO) have a significant impact on patient's quality of everyday life, and early diagnosis is critical for the symptoms management and prognosis. There is evidence that HT and PsO share common metabolic pathways that relate to their pathogenesis, and are affected by dietary and lifestyle factors. Previous studies have identified potential metabolic biomarkers, although the small number of studies hamper their validation. Of note, most studies are not longitudinal thus do not capture the metabolic fluctuations in response to disease progression or dietary changes. Thus, the purpose of this study is to identify metabolic biomarkers of HT and PsO and study the role of epigenetic factors (diet and lifestyle) on the involved metabolic pathways . In addition, a comparative analysis of the disease-related quality of life (QoL) will be performed in relation to dietary changes to unravel possible links between the QoL and the associated metabolic pathways in HT and PsO.

Full description

Patients with Hashimoto's thyroiditis (HT), patients with psoriasis (PsO), and healthy individuals aged 18-60 will be recruited and assessed according to inclusion/exclusion criteria. Eligible participants will be randomized to two groups. The intervention group will receive a combinational nutraceuticals plan for 6 months as part of a Mediterranean diet and the control group will follow usual diet. Data will be collected at baseline and at the end of the study including levels of organic and fatty acids, lifestyle and anthropometric measurements, adherence to Mediterranean diet through the Mediterranean Diet Score (MDS) and disease-specific quality of life through the Thyroid Patient Report Outcome (THYPRO) and the Dermatology Life Quality Index (DLQI) questionnaires for the HT and the PsO group respectively.

Enrollment: 200 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Hashimoto's Thyroiditis:

• Clinical findings
• Presence of thyroid autoantibodies (anti-TPO) in laboratory tests
• Gray-scale Ultrasound findings.

Psoriasis:

• Presence of psoriatic lesions
• Psoriasis Area and Severity Index score (PASI).

Healthy group:

Non-obese (BMI<30)

• non-athletes
• non-pregnant or lactating women
• not been diagnosed with a chronic or acute disease
• not receiving antidepressants, drugs and supplements
• normal Thyroid Stimulating Hormone (TSH) levels or high TSH and absence of other clinical findings of thyroid malfunction.

Exclusion Criteria:

• malignant or congenital goiter
• thyroidectomy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Nutraceuticals

Active Comparator group

Description:

Participants will receive a combination of nutraceuticals and will be instructed to follow a Mediterranean diet

Treatment:

Combination Product: Nutraceutical Combination Plan

Control

No Intervention group

Description:

Participants will follow usual diet