An interventional study of Nutraceutical Combination Plan in Hashimoto Disease and Psoriasis, sponsored by University of Crete. Active, not recruiting at 1 site in Greece. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by University of Crete · Not applicable, Interventional, and Diagnostic
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.
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.
53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 31 interventional studies indexed under Hashimoto Disease.
Browse Hashimoto Disease studies →University of Crete is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hashimoto's Thyroiditis:
Psoriasis:
Healthy group:
Non-obese (\<30)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a combination of nutraceuticals and will be instructed to follow a Mediterranean diet
Combination Product: Nutraceutical Combination Plan
Participants will follow usual 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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Change from baseline Body Mass Index at 6 months of intervention with nutraceuticals
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
Time frame: 6 months
Change from baseline waist circumference at 6 months of intervention with nutraceuticals
Waist circumference (cm) will be measured at baseline and 6 months post the intervention for the three groups (both arms).
Time frame: 6 months
Change from baseline alcohol consumption at 6 months of intervention with nutraceuticals
Alcohol consumption (number of glasses per week) will be assessed at baseline and 6 months post the intervention for all participants (both arms).
Time frame: 6 months
Change from baseline physical activity at 6 months of intervention with nutraceuticals
Physical activity frequency (times per week) will be assessed at baseline and 6 months post the intervention for all participants (both arms).
Time frame: 6 months
Change from baseline smoking at 6 months of intervention with nutraceuticals
Smoking (cigars per day) will be assessed at baseline and 6 months post the intervention for all participants(both arms).
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Sep 2024, 43 months after the start.
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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Crete