Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT

NCT07438652 | Recruiting

• 1 other identifier: CU-FM-RA-DIET-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Dietary Intervention; Rheumatoid arthritis; Paleolitic Diet; Mediterranean Diet; Sarcopenia; Quality of life; Nutrition

Outcome Measures

Primary Outcomes (2)

• 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

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)

  12 weeks

• Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change of the body mass index (BMI)

  12 weeks

• Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in Waist-to-Hip Ratio (WHR)

  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)

  12 weeks

• Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in Hemoglobin (HB).

  12 weeks

Study Arms (3)

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)

Interventions

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.

Mediterranean Diet (MD)

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.

Paleolithic Diet (PD)

Control (Usual Diet) OTHER

Participants will continue their habitual diet without specific dietary modifications. General healthy eating advice may be provided.

Control (usual diet)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with comorbidities (e.g., diabetes mellitus, hypertension, gout, thyroid dysfunction).

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University

Cairo, Al-Manial, 11956, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 36598468 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.

  PMID: 34902577 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.

  PMID: 37227116 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.

  PMID: 28526915 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.

  PMID: 40181632 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sarcopenia

Interventions

Diet, Mediterranean; Diet, Paleolithic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Gehad Maghraby, MD

CONTACT

+201027491363; gehad.maghraby@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Internal Medicine Department, Rheumatology and Clinical Immunology Division, Faculty of Medicine, Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 27, 2026
• Study Start: January 17, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)