Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis

NCT04693936 | Active Not Recruiting

• 1 other identifier: 147/26.06.2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hashimoto Disease; Psoriasis

Keywords

metabolomics; biomarkers; metabolic pathways

Outcome Measures

Primary Outcomes (7)

• Differential levels of urinary organic acids in patients with Hashimoto's thyroiditis and psoriasis compared to healthy individuals as assessed by GC-MS

  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

  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

  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

  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

  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

  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

  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 Outcomes (5)

• Change from baseline Body Mass Index at 6 months of intervention with nutraceuticals

  6 months

• Change from baseline waist circumference at 6 months of intervention with nutraceuticals

  6 months

• Change from baseline alcohol consumption at 6 months of intervention with nutraceuticals

  6 months

• Change from baseline physical activity at 6 months of intervention with nutraceuticals

  6 months

• Change from baseline smoking at 6 months of intervention with nutraceuticals

  6 months

Study Arms (2)

Nutraceuticals

ACTIVE COMPARATOR

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

Combination Product: Nutraceutical Combination Plan

Control

NO INTERVENTION

Participants will follow usual diet

Interventions

Nutraceutical Combination Plan 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.

Nutraceuticals

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• malignant or congenital goiter
• thyroidectomy

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

Metabolomic Medicine, Private Health Clinics

Athens, Greece

Location

MeSH Terms

Conditions

Hashimoto Disease; Psoriasis

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aristidis Tsatsakis, PhD, Prof

  University of Crete

  STUDY CHAIR

• Sabine Kruger-Krasagakis, MD,Ass Prof

  University of Crete

  PRINCIPAL INVESTIGATOR

• Gottfried Rudofsky, MD, Prof.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biologist, MSc, PhD student

Model Details: 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

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 5, 2021
• Study Start: February 2, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)