Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

• ClinicalTrials.gov Identifier: NCT04693936
• Recruitment Status: Recruiting
• First Posted: January 5, 2021
• Last Update Posted: February 16, 2021
• Sponsor: University of Crete
• Information provided by (Responsible Party): Evangelia Sarandi, University of Crete

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hashimoto Disease; Psoriasis	Combination Product: Nutraceutical Combination Plan	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Study of Metabolic Pathways for the Identification of Biomarkers in Hashimoto's Thyroiditis and Psoriasis
• Actual Study Start Date: February 2, 2021
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nutraceuticals; Participants will receive a combination of nutraceuticals and will be instructed to follow a Mediterranean diet	Combination Product: Nutraceutical Combination Plan; 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.
No Intervention: Control; Participants will follow usual diet

Outcome Measures

Primary Outcome Measures :

1. Differential levels of urinary organic acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS [ Time Frame: 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

2. Differential levels of peripheral blood fatty acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS [ Time Frame: 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

3. Change from baseline urinary organic acids levels after 6-month intervention with nutraceuticals as assessed by GC-MS [ Time Frame: 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

4. Change from baseline peripheral blood fatty acids levels after the 6-month intervention with nutraceuticals as assessed by GC-MS [ Time Frame: 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

5. Change from baseline thyroid disease-related quality of life at 6-months of intervention with nutraceuticals as assessed by the THYPRO questionnaire [ Time Frame: 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.

6. Change from baseline psoriasis-related quality of life at 6-months of intervention with nutraceuticals as assessed by the DLQI questionnaire [ Time Frame: 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.

7. Change from baseline Mediterranean diet adherence at 6 months of intervention with nutraceuticals as assessed by the MDS questionnaire [ Time Frame: 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 Outcome Measures :

1. Change from baseline Body Mass Index at 6 months of intervention with nutraceuticals [ Time Frame: 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

2. Change from baseline waist circumference at 6 months of intervention with nutraceuticals [ Time Frame: 6 months ]
   Waist circumference (cm) will be measured at baseline and 6 months post the intervention for the three groups (both arms).
3. Change from baseline alcohol consumption at 6 months of intervention with nutraceuticals [ Time Frame: 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).
4. Change from baseline physical activity at 6 months of intervention with nutraceuticals [ Time Frame: 6 months ]
   Physical activity frequency (times per week) will be assessed at baseline and 6 months post the intervention for all participants (both arms).
5. Change from baseline smoking at 6 months of intervention with nutraceuticals [ Time Frame: 6 months ]
   Smoking (cigars per day) will be assessed at baseline and 6 months post the intervention for all participants(both arms).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Evangelia Sarandi, MSc, PhDc; +306945546993; esarandi6@hotmail.com

Locations

Greece

Metabolomic Medicine, Private Health Clinics; Recruiting

Athens, Greece

Contact: Evangelia Sarandi, MSc, PhDc +306945546993

Sub-Investigator: Aristidis Tsatsakis, PhD, Prof

Sub-Investigator: Dimitris Tsoukalas, MD

Sponsors and Collaborators

University of Crete

Investigators

• Study Chair: Aristidis Tsatsakis, PhD, Prof; University of Crete
• Principal Investigator: Sabine Kruger-Krasagakis, MD,Ass Prof; University of Crete
• Principal Investigator: Gottfried Rudofsky, MD, Prof.; Heidelberg University

More Information

• Responsible Party: Evangelia Sarandi, Biologist, MSc, PhD student, University of Crete
• ClinicalTrials.gov Identifier: NCT04693936
• Other Study ID Numbers: 147/26.06.2020
• First Posted: January 5, 2021
• Last Update Posted: February 16, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evangelia Sarandi, University of Crete:

metabolomics; biomarkers; metabolic pathways

Additional relevant MeSH terms:

Psoriasis; Thyroiditis; Hashimoto Disease; Skin Diseases, Papulosquamous; Skin Diseases; Thyroid Diseases; Endocrine System Diseases; Thyroiditis, Autoimmune