Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04693936
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Crete
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Aristidis Tsatsakis, PhD, ProfSabine Kruger-Krasagakis, MD,Ass ProfGottfried Rudofsky, MD, Prof.
Principal Investigator Affiliation University of CreteUniversity of CreteHeidelberg University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Greece
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hashimoto Disease, Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Nutraceuticals

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

No Intervention: Control

Participants will follow usual diet

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.

Contact a Trial Team

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International Sites

Athens, Greece

Status

Recruiting

Address

Metabolomic Medicine, Private Health Clinics

Athens, ,

Site Contact

Evangelia Sarandi, MSc, PhDc

esarandi6@hotmail.com

+306945546993

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