Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

NCT04693936 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Crete

    lead OTHER

Principal Investigators

  • Aristidis Tsatsakis, PhD, Prof · University of Crete

  • Sabine Kruger-Krasagakis, MD,Ass Prof · University of Crete

  • Gottfried Rudofsky, MD, Prof. · Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693936 on ClinicalTrials.gov