Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

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.

• Nutraceutical Combination Plan (Combination product): Multivitamin (My Total Health) 1 tablet per day Vitamin C (My Immuno) 1 scoop per day Calcium-Magnesium combination (My Calmag) 1 scoop per day Omega 3-6-9 My Omega Krill. 1 capsule per day Glutamine (L-Glutamin \&Chios Mastiha) 1 tablet per day Probiotics 40 billion 1 capsule per day Nutraceuticals will be received daily along with the patient's customary psoriasis/Hashimoto's disease treatment.

Primary outcomes

• Differential levels of urinary organic acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS [Baseline]: Levels of organic acids will be quantified in the urine of patients with Hashimoto's diseases and psoriasis and the healthy group at baseline. Concentrations will be calculated in relation to creatinine (mmol/mol Crea) using Gas Chromatography-Mass Spectrometry (GC-MS). Comparisons will be made at organic acids concentrations between the HT, the PSO and the healthy group to determine disease-related differences
• Differential levels of peripheral blood fatty acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS [Baseline]: Levels of total fatty acids will be quantified (μmol/l) in the peripheral blood of patients with Hashimoto's diseases and psoriasis and the healthy group at baseline using Gas Chromatography-Mass Spectrometry (GC-MS) Comparisons will be made at fatty acids concentrations between the HT, the PSO and the healthy group to determine disease-related differences
• Change from baseline urinary organic acids levels after 6-month intervention with nutraceuticals as assessed by GC-MS [6 months]: Levels of organic acids will be quantified in the urine of patients with Hashimoto's diseases and psoriasis and the healthy group after 6 months of intervention. Concentrations will be calculated in relation to creatinine (mmol/mol Crea). Comparisons will be made at organic acids concentrations between baseline levels and post 6 months treatment in the HT, the PSO and the healthy group to determine intervention-related differences
• Change from baseline peripheral blood fatty acids levels after the 6-month intervention with nutraceuticals as assessed by GC-MS [6 months]: Levels of total fatty acids will be quantified (μmol/l) in the peripheral blood of patients with Hashimoto's diseases and psoriasis and the healthy group after 6 months of intervention. Comparisons will be made at fatty acids concentrations between baseline levels and post 6 months of treatment in the HT, the PSO and the healthy group to determine intervention-related differences
• Change from baseline thyroid disease-related quality of life at 6-months of intervention with nutraceuticals as assessed by the THYPRO questionnaire [6 months]: The Thyroid Patient Response Outcome (THYPRO) questionnaire will be completed by the HT group at baseline and 6 months post intervention (both arms). THYPRO score (0-100) after the intervention will be compared with baseline.
• Change from baseline psoriasis-related quality of life at 6-months of intervention with nutraceuticals as assessed by the DLQI questionnaire [6 months]: The Dermatology Life Quality Index (DLQI) will be completed by the HT group and the PSO group (both arms) at baseline and 6 months post intervention. DLQI score (0-30) after the intervention will be compared with baseline.
• Change from baseline Mediterranean diet adherence at 6 months of intervention with nutraceuticals as assessed by the MDS questionnaire [6 months]: The Mediterranean Diet Score (MDS) questionnaire will be collected for all participants (both arms) at baseline and 6 months post the intervention. MDS (0-17) after the intervention will be compared with baseline.

Secondary outcomes

• Change from baseline Body Mass Index at 6 months of intervention with nutraceuticals [6 months]: BMI will be estimated at baseline and 6 months post the intervention for the three groups (both arms). For the estimation of BMI (kg/m\^2) weight and height will be combined
• Change from baseline waist circumference at 6 months of intervention with nutraceuticals [6 months]: Waist circumference (cm) will be measured at baseline and 6 months post the intervention for the three groups (both arms).
• Change from baseline alcohol consumption at 6 months of intervention with nutraceuticals [6 months]: Alcohol consumption (number of glasses per week) will be assessed at baseline and 6 months post the intervention for all participants (both arms).
• Change from baseline physical activity at 6 months of intervention with nutraceuticals [6 months]: Physical activity frequency (times per week) will be assessed at baseline and 6 months post the intervention for all participants (both arms).
• Change from baseline smoking at 6 months of intervention with nutraceuticals [6 months]: Smoking (cigars per day) will be assessed at baseline and 6 months post the intervention for all participants(both arms).

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

• Aristidis Tsatsakis, PhD, Prof, Study chair, University of Crete
• Sabine Kruger-Krasagakis, MD,Ass Prof, Principal investigator, University of Crete
• Gottfried Rudofsky, MD, Prof., Principal investigator, Heidelberg University