- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04693936
Metabolic Biomarkers in Hashimoto's Thyroiditis and Psoriasis
Study of Metabolic Pathways for the Identification of Biomarkers in Hashimoto's Thyroiditis and Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Evangelia Sarandi, MSc, PhDc
- Phone Number: +306945546993
- Email: esarandi6@hotmail.com
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 147/26.06.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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