Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hashimoto Disease Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nutraceuticals

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

Group Type ACTIVE_COMPARATOR

Nutraceutical Combination Plan

Intervention Type 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.

Control

Participants will follow usual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT