Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

April 27, 2023 updated by: Evangelia Sarandi, University of Crete

Study of Metabolic Pathways for the Identification of Biomarkers in Hashimoto's Thyroiditis and Psoriasis

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.

Study Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Athens, Greece
        • Recruiting
        • Metabolomic Medicine, Private Health Clinics
        • Contact:
          • Evangelia Sarandi, MSc, PhDc
          • Phone Number: +306945546993
        • Sub-Investigator:
          • Aristidis Tsatsakis, PhD, Prof
        • Sub-Investigator:
          • Dimitris Tsoukalas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutraceuticals
Participants will receive a combination of nutraceuticals and will be instructed to follow a Mediterranean diet

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Baseline
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

Baseline
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

6 months
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

6 months
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 months
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.

6 months
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.

6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

6 months
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).
6 months
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).
6 months
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).
6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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