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This study aims to evaluate the effects of Mediterranean and Paleolithic dietary interventions on nutritional status, disease activity, fatigue, sleep, and quality of life in adults with rheumatoid arthritis (RA). Participants aged 40-60 years will be randomly assigned to follow either a Mediterranean diet, a Paleolithic diet, or continue their usual diet for 12 weeks. The study will assess anthropometric measurements, disease activity score (DAS28), laboratory biomarkers (CBC, CRP, ESR, lipid profile, fasting glucose, HbA1c), and patient-reported outcomes. The trial will determine whether these diets improve RA management and overall well-being.
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by progressive erosive polyarthritis, impaired physical function, and reduced quality of life. Patients with RA are at increased risk of comorbidities such as cardiovascular disease, osteoporosis, infections, and mortality due to ongoing inflammation and long-term immunosuppressive therapy.
Diet and nutrition have gained attention as potential modulators of RA activity, partly due to their effects on systemic inflammation, gut microbiota, and antioxidant status. The Mediterranean diet (MD), rich in fruits, vegetables, olive oil, and limited meat, has shown beneficial effects on cardiovascular health, RA symptoms, and quality of life, although evidence is still of moderate certainty. The Paleolithic diet (PD), emphasizing lean meats, fish, fruits, vegetables, nuts, and seeds while excluding grains, dairy, and processed foods, has shown promising anti-inflammatory effects in autoimmune conditions, metabolic improvements, and reduction of RA-related symptoms in preliminary studies.
This randomized controlled trial will recruit adults aged 40-60 years with RA from the Kasr Al-Ainy Internal Medicine Inpatient and Outpatient Rheumatology Clinics. Participants will be randomly assigned to one of three groups: Mediterranean diet, Paleolithic diet, or control (usual diet) for 12 weeks. Baseline and post-intervention assessments will include:
Nutritional assessment via Food Frequency Questionnaire and Nutrition Awareness Questionnaire
Anthropometric measurements: weight, height, BMI, waist, and hip circumference
RA disease activity using DAS28
Laboratory investigations: CBC, CRP, ESR, lipid profile, fasting glucose, HbA1c
Patient-reported outcomes: fatigue, sleep quality, stress, and quality of life
The primary objective is to evaluate whether dietary interventions improve nutritional status and RA disease activity. Secondary objectives include comparing the effects of MD and PD on fatigue, sleep, stress, and overall quality of life. The study seeks to provide evidence for dietary strategies as adjunctive management for RA, improving both clinical and metabolic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet (MD) | Active Comparator |
| |
| Paleolithic Diet (PD) | Active Comparator |
| |
| Control (usual diet) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet (MD) | Other | Participants will follow a Mediterranean diet for 12 weeks, emphasizing fruits, vegetables, whole grains, legumes, fish, and olive oil, with limited red meat and processed foods. Nutritional counseling and meal plans will be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in the Rheumatoid Arthritis Disease Activity Score-28 (DAS-28 score) | Disease activity will be evaluated using the Disease Activity Score based on 28 joints (DAS-28), a validated composite index that includes the number of tender and swollen joints (28-joint count), erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global health assessment. The DAS-28 score ranges from 0 to 9.4, with higher scores indicating greater disease activity. The rate of change will be determined by calculating the difference in DAS-28 scores from baseline to the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of mediterranean diet and plaeolithic diet on rate of change of World Health Organization quality of life questionnaire (WHOQOL-BREF) | Quality of life will be assessed using WHOQOL-BREF, a validated instrument that evaluates four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life. The rate of improvement will be determined by calculating the change in domain and total scores from baseline to the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of mediterranean diet and plaeolithic diet on incidence of sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP2, 2019) | Sarcopenia will be defined according to EWGSOP2 criteria as the presence of low muscle strength and low muscle mass. Low muscle strength will be assessed by handgrip dynamometry (<27 kg in men and <16 kg in women). Low muscle mass will be measured using bioelectrical impedance analysis (BIA) and expressed as appendicular skeletal muscle mass index (ASMI), with cut-off values of <7.0 kg/m² in men and <5.5 kg/m² in women. Physical performance will be evaluated using gait speed (≤0.8 m/s) to classify severe sarcopenia. Incidence will be defined as the proportion of participants who develop sarcopenia during the intervention period (from baseline to 12 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gehad Maghraby, MD | Contact | +201027491363 | gehad.maghraby@kasralainy.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University | Recruiting | Cairo | Al-Manial | 11956 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36598468 | Background | Hollywood JB, Hutchinson D, Feehery-Alpuerto N, Whitfield M, Davis K, Johnson LM. The Effects of the Paleo Diet on Autoimmune Thyroid Disease: A Mixed Methods Review. J Am Nutr Assoc. 2023 Nov-Dec;42(8):727-736. doi: 10.1080/27697061.2022.2159570. Epub 2023 Jan 4. | |
| 34902577 | Background | Daien C, Czernichow S, Letarouilly JG, Nguyen Y, Sanchez P, Sigaux J, Beauvais C, Desouches S, Le Puillandre R, Rigalleau V, Riviere P, Romon M, Semerano L, Seror R, Sfedj S, Tournadre A, Vacher D, Wendling D, Flipo RM, Sellam J. Dietary recommendations of the French Society for Rheumatology for patients with chronic inflammatory rheumatic diseases. Joint Bone Spine. 2022 Mar;89(2):105319. doi: 10.1016/j.jbspin.2021.105319. Epub 2021 Dec 10. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| D066046 | Diet, Paleolithic |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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This study is a randomized, controlled, parallel-group clinical trial designed to evaluate the effects of dietary interventions on patients with rheumatoid arthritis (RA). Participants aged 40-60 years, of both sexes, will be recruited from the Internal Medicine Department at Kasr Alainy, Cairo University. Eligible participants will be randomly assigned to one of three groups:
Mediterranean Diet (MD) group: Participants will follow a structured Mediterranean diet emphasizing fruits, vegetables, whole grains, olive oil, and limited meat.
Paleolithic Diet (PD) group: Participants will follow a Paleolithic diet emphasizing lean meats, fish, eggs, fruits, vegetables, nuts, and seeds while excluding grains, legumes, dairy, processed foods, refined sugars, and added salt.
Control group: Participants will continue their usual diet without any structured dietary intervention.
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This is a randomized, controlled, interventional study comparing the effects of Mediterranean and Paleolithic diets on patients with rheumatoid arthritis. The participants will be unaware of which specific diet group they are assigned to (partial participant blinding). The rheumatologist assessing disease activity, fatigue, and other clinical outcomes will be blinded to the participants' group assignments to minimize assessment bias. Additionally, the statistician performing the data analysis will be blinded to group allocation to ensure objective evaluation of study outcomes. Only the dietitian responsible for delivering the dietary intervention will have access to group assignments.
| Paleolithic Diet (PD) | Other | Participants will follow a Paleolithic diet for 12 weeks, focusing on lean meats, fish, fruits, vegetables, eggs, nuts, and seeds, while excluding grains, legumes, dairy, processed foods, refined sugars, and added salt. Nutritional counseling and meal plans will be provided. |
|
| Control (Usual Diet) | Other | Participants will continue their habitual diet without specific dietary modifications. General healthy eating advice may be provided. |
|
| 12 weeks |
| Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change of the body mass index (BMI) | Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Body weight and height will be measured using standardized procedures. The rate of change in BMI will be determined by calculating the difference between baseline and the end of the intervention period ([insert duration, e.g., 12 weeks]) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in Waist-to-Hip Ratio (WHR) | Waist circumference (cm) and hip circumference (cm) will be measured using a non-stretchable measuring tape according to standardized protocols. Waist-to-hip ratio (WHR) will be calculated as waist circumference divided by hip circumference. The rate of change in WHR will be determined by calculating the difference between baseline and the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in muscle mass assessed by Bioelectrical Impedance Analysis (BIA) | Muscle mass will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions. Appendicular skeletal muscle mass index (ASMI, kg/m²) will be calculated as appendicular skeletal muscle mass divided by height squared. The rate of change in ASMI will be determined by calculating the difference between baseline and the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in Hemoglobin (HB). | Hemoglobin (HB) levels will be measured in g/dL using standard laboratory methods. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in C-Reactive Protein (CRP). | C-reactive protein (CRP) levels will be measured in mg/L using standardized laboratory assays. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in Erythrocyte Sedimentation Rate (ESR). | Erythrocyte sedimentation rate (ESR) will be measured in mm/hour using standard laboratory methods. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in Fasting Blood Glucose (FBG) | Fasting blood glucose (FBG) will be measured in mg/dL after an overnight fast of at least 8 hours using standard laboratory techniques. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in Total cholesterol level (mg/dL) | Total cholesterol will be measured after an overnight fast using standard laboratory assays (mg/dL). The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in Low-density lipoprotein cholesterol (LDL-C, mg/dL) | LDL-C will be measured after an overnight fast using standard laboratory assays. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in High-density lipoprotein cholesterol (HDL-C, mg/dL) | HDL-C will be measured after an overnight fast using standard laboratory assays. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in Triglycerides (mg/dL) | Triglycerides will be measured after an overnight fast using standard laboratory assays. The rate of change will be determined by calculating the difference between baseline and 12 weeks and comparing the mean change between the Mediterranean diet and Paleolithic diet groups. | 12 weeks |
| 37227116 | Background | England BR, Smith BJ, Baker NA, Barton JL, Oatis CA, Guyatt G, Anandarajah A, Carandang K, Chan KK, Constien D, Davidson E, Dodge CV, Bemis-Dougherty A, Everett S, Fisher N, Fraenkel L, Goodman SM, Lewis J, Menzies V, Moreland LW, Navarro-Millan I, Patterson S, Phillips LR, Shah N, Singh N, White D, AlHeresh R, Barbour KE, Bye T, Guglielmo D, Haberman R, Johnson T, Kleiner A, Lane CY, Li LC, Master H, Pinto D, Poole JL, Steinbarger K, Sztubinski D, Thoma L, Tsaltskan V, Turgunbaev M, Wells C, Turner AS, Treadwell JR. 2022 American College of Rheumatology Guideline for Exercise, Rehabilitation, Diet, and Additional Integrative Interventions for Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1603-1615. doi: 10.1002/acr.25117. Epub 2023 May 25. |
| 28526915 | Background | Afifi L, Danesh MJ, Lee KM, Beroukhim K, Farahnik B, Ahn RS, Yan D, Singh RK, Nakamura M, Koo J, Liao W. Dietary Behaviors in Psoriasis: Patient-Reported Outcomes from a U.S. National Survey. Dermatol Ther (Heidelb). 2017 Jun;7(2):227-242. doi: 10.1007/s13555-017-0183-4. Epub 2017 May 19. |
| 40181632 | Background | McNeill J, Zinn C, Mearns G, Grainger R. Elimination reintroduction diets and oral food challenge in adults with rheumatoid arthritis: a scoping review. Nutr Res Rev. 2025 Dec;38(2):699-716. doi: 10.1017/S0954422425000083. Epub 2025 Apr 4. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |