Clinical trial NCT04693936: Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis
Official title: Study of Metabolic Pathways for the Identification of Biomarkers in Hashimoto's Thyroiditis and Psoriasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hashimoto Disease
Psoriasis
Keywords: metabolomics
biomarkers
metabolic pathways
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with Hashimoto's disease and patients with psoriasis and healthy individuals will be randomly assigned to intervention group and to control group. The intervention will be a nutraceuticals supplements combination in the context of Mediterranean diet. The duration of the intervention will last 6 months
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Differential levels of urinary organic acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS
timeFrame: Baseline
measure: Differential levels of peripheral blood fatty acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS
timeFrame: Baseline
measure: Change from baseline urinary organic acids levels after 6-month intervention with nutraceuticals as assessed by GC-MS
timeFrame: 6 months
measure: Change from baseline peripheral blood fatty acids levels after the 6-month intervention with nutraceuticals as assessed by GC-MS
timeFrame: 6 months
measure: Change from baseline thyroid disease-related quality of life at 6-months of intervention with nutraceuticals as assessed by the THYPRO questionnaire
timeFrame: 6 months
measure: Change from baseline psoriasis-related quality of life at 6-months of intervention with nutraceuticals as assessed by the DLQI questionnaire
timeFrame: 6 months
measure: Change from baseline Mediterranean diet adherence at 6 months of intervention with nutraceuticals as assessed by the MDS questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline Body Mass Index at 6 months of intervention with nutraceuticals
timeFrame: 6 months
measure: Change from baseline waist circumference at 6 months of intervention with nutraceuticals
timeFrame: 6 months
measure: Change from baseline alcohol consumption at 6 months of intervention with nutraceuticals
timeFrame: 6 months
measure: Change from baseline physical activity at 6 months of intervention with nutraceuticals
timeFrame: 6 months
measure: Change from baseline smoking at 6 months of intervention with nutraceuticals
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Metabolomic Medicine, Private Health Clinics
Study officials:
affiliation: University of Crete
name: Aristidis Tsatsakis, PhD, Prof
role: STUDY_CHAIR
affiliation: University of Crete
name: Sabine Kruger-Krasagakis, MD,Ass Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Gottfried Rudofsky, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: