Rheumatoid Arthritis (RA)NCT07438652
Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT
A study testing Mediterranean Diet (MD) and Paleolithic Diet (PD) in people with Rheumatoid Arthritis (RA), run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Mediterranean Diet (MD) and Paleolithic Diet (PD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients classified as having rheumatoid arthritis according to the 2010 rheumatoid arthritis ACR/ EULAR classification criteria with a selected age group of 40 to 60 years old.
Who cannot join
- Patients with comorbidities (e.g., diabetes mellitus, hypertension, gout, thyroid dysfunction).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University
Cairo, Al-Manial, 11956
Gehad Maghraby, M.D., +201027491361, gehad.maghraby@kasralainy.edu.eg
About this study
Official title: Effect of Mediterranean and Paleolithic Dietary Interventions on Nutritional Status, Disease Activity, Sarcopenia, and Quality of Life in Adults With Rheumatoid Arthritis: A 12-Week Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Mediterranean Diet (MD), Paleolithic Diet (PD), Control (Usual Diet)
- Keywords
- Dietary Intervention, Rheumatoid arthritis, Paleolitic Diet, Mediterranean Diet, Sarcopenia, Quality of life, Nutrition
- Medical subject headings
- Arthritis, Rheumatoid, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet (MD) | Active comparator | Not described Receives: Other: Mediterranean Diet (MD) |
| Paleolithic Diet (PD) | Active comparator | Not described Receives: Other: Paleolithic Diet (PD) |
| Control (usual diet) | Placebo comparator | Not described Receives: Other: Control (Usual Diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start17 Jan 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Maghraby, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438652
- Sponsor's protocol ID
- CU-FM-RA-DIET-001
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36598468Daien 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.
PubMed 34902577England 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.
PubMed 37227116Afifi 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.
PubMed 28526915McNeill 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.
PubMed 40181632
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mediterranean and Paleolithic Dietary Interventions on Nutritional Status, Disease Activity, Sarcopenia, and Quality of Life in Adults With Rheumatoid Arthritis: A 12-Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07438652
- Acronym / sponsor ID
- CU-FM-RA-DIET-001
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Dietary Intervention, Rheumatoid arthritis, Paleolitic Diet, Mediterranean Diet, Sarcopenia, Quality of life, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet (MD) | Active comparator | Other: Mediterranean Diet (MD) |
| Paleolithic Diet (PD) | Active comparator | Other: Paleolithic Diet (PD) |
| Control (usual diet) | Placebo comparator | Other: Control (Usual Diet) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients classified as having rheumatoid arthritis according to the 2010 rheumatoid arthritis ACR/ EULAR classification criteria with a selected age group of 40 to 60 years old.
Key exclusion criteria (1 listed)
- Patients with comorbidities (e.g., diabetes mellitus, hypertension, gout, thyroid dysfunction).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet (MD)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. | Other | Mediterranean Diet (MD) |
| Paleolithic Diet (PD)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. | Other | Paleolithic Diet (PD) |
| Control (Usual Diet)Participants will continue their habitual diet without specific dietary modifications. General healthy eating advice may be provided. | Other | Control (usual diet) |
Primary outcome
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)
Time frame: 12 weeks
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.
Compare the effect of mediterranean diet and plaeolithic diet on rate of change of World Health Organization quality of life questionnaire (WHOQOL-BREF)
Time frame: 12 weeks
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 secondary outcomes
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)
Time frame: 12 weeks
Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change of the body mass index (BMI)
Time frame: 12 weeks
Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in Waist-to-Hip Ratio (WHR)
Time frame: 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)
Time frame: 12 weeks
Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in Hemoglobin (HB).
Time frame: 12 weeks
Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in C-Reactive Protein (CRP).
Time frame: 12 weeks
Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in Erythrocyte Sedimentation Rate (ESR).
Time frame: 12 weeks
Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in Fasting Blood Glucose (FBG)
Time frame: 12 weeks
Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in Total cholesterol level (mg/dL)
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks
Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in Triglycerides (mg/dL)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 36598468Hollywood 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.
- Background: PubMed 34902577Daien 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.
- Background: PubMed 37227116England 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.
- Background: PubMed 28526915Afifi 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.
- Background: PubMed 40181632McNeill 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet (MD) and Paleolithic Diet (PD) in people with Rheumatoid Arthritis (RA), run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gehad Maghraby, MD (+201027491363, gehad.maghraby@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438652, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.