Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis
Investigation of the Effects of a Gluten-Free Diet and the Mediterranean Diet on the Inflammatory Index, Disease Activity, and Quality of Life in Patients With Rheumatoid Arthritis.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study is a 12-week dietary intervention trial conducted in patients with rheumatoid arthritis. Participants will be assigned to three different dietary groups: gluten-free diet, Mediterranean diet, and control diet. The aim is to investigate the effects of these dietary patterns on disease activity, quality of life, and dietary inflammatory index.
Disease activity will be assessed using the DAS28 score, while quality of life will be evaluated using the SF-12 questionnaire. Dietary inflammatory index (DII) will be calculated based on dietary intake data collected throughout the study period.
Participants will be followed regularly during the 12-week intervention period, and changes in clinical and nutritional outcomes will be analyzed to determine the impact of dietary patterns on rheumatoid arthritis progression and patient well-being.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Nilüfer Gürsel, PhD
- Telefonnummer: +90 506 379 73 42
- E-post: nilufergursell@gmail.com
Studera Kontakt Backup
- Namn: Mine Yurttagül, Prof. Dr.
- E-post: mine@yurttagul.com
Studieorter
-
-
Şehitkamil
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Gaziantep, Şehitkamil, Turkiet (Türkiye), 27560
- Rekrytering
- NCR International Hospital
-
Kontakt:
- Nilüfer Gürsel, PhD
- Telefonnummer: +90 506 379 73 42
- E-post: nilufergursell@gmail.com
-
Huvudutredare:
- Nilüfer Gürsel, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria Age between 19-65 years Stable medication regimen for at least 3 months prior to enrollment Willingness to comply with dietary interventions and study procedures Ability to provide informed consent
Exclusion Criteria:
Pregnancy or lactation Presence of other autoimmune or inflammatory diseases (e.g., SLE, IBD) Severe comorbidities (e.g., advanced cardiovascular, renal, or hepatic disease) Use of special diets (e.g., gluten-free diet) in the last 3 months Recent change in biologic or corticosteroid therapy (<3 months) Food allergies or intolerances affecting dietary intervention adherence Inability to comply with dietary protocol or follow-up visits
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Gluten-Free Diet Group
Participants will follow a gluten-free diet for 12 weeks.
All gluten-containing foods will be eliminated, and dietary guidance will be provided throughout the intervention period.
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Participants will follow a gluten-free diet in which all wheat, barley, rye, and their derivatives are eliminated for 12 weeks.
The diet focuses on naturally gluten-free foods such as fruits, vegetables, legumes, meat, fish, rice, and corn.
|
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Experimentell: Mediterranean Diet Group
Participants will follow a Mediterranean diet for 12 weeks, emphasizing high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with limited processed foods.
|
Participants will follow a Mediterranean dietary pattern characterized by high intake of fruits, vegetables, whole grains, legumes, olive oil, and fish, with moderate consumption of dairy and low intake of red meat and processed foods for 12 weeks.
|
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Aktiv komparator: Control Diet Group
Participants will continue their usual diet without specific dietary modifications.
General dietary advice may be provided but no structured intervention will be implemented.
|
Participants will continue their habitual diet without any specific dietary restrictions or structured dietary guidance during the 12-week study period.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disease Activity (DAS28)
Tidsram: 12 weeks
|
Change in Disease Activity Score 28 (DAS28) from baseline to 12 weeks.
Disease activity will be assessed using the DAS28 scoring system to evaluate changes in rheumatoid arthritis activity following dietary interventions.
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Life (SF-12)
Tidsram: Baseline 12 weeks
|
Change in SF-12 health-related quality of life scores from baseline to 12 weeks.
The SF-12 questionnaire will be used to assess physical and mental health status in patients with rheumatoid arthritis following dietary interventions.
|
Baseline 12 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Muskuloskeletala sjukdomar
- Artrit
- Ledsjukdomar
- Reumatiska sjukdomar
- Bindvävssjukdomar
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Hud- och bindvävssjukdomar
- Artrit, reumatoid
- Terapeutik
- Diet, mat och näring
- Fysiologiska fenomen
- Näringsfysiologiska fenomen
- Diet, växtbaserad
- Dieterapi
- Näringsterapi
- Diet
- Diet, Medelhavet
Andra studie-ID-nummer
- HasanKU-NUT-NG-01
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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