Ketogenic Diet in Rheumatoid Arthritis (RA)

NCT05799768 | Enrolling By Invitation

• 1 other identifier: 2020H0090
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.

Conditions

Rheumatoid Arthritis; Inflammation; Obesity; Ketogenic Dieting; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• hsCRP

  Systemic marker of inflammation

  6 weeks

Secondary Outcomes (1)

• DAS28-CRP

  6 weeks

Study Arms (1)

Ketogenic diet plan

EXPERIMENTAL

Subjects will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home whole capillary blood ketone/glucose monitors, along with diet records. We will assess adherence based on days in ketosis following these parameters: (BHB ≥ 0.5mM). Adherence will be defined as \> 80% of days in ketosis.

Behavioral: Ketogenic diet

Interventions

Ketogenic diet BEHAVIORAL

Ketogenic diet counseling

Ketogenic diet plan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.
• On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)

You may not qualify if:

• Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
• Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
• Insulin use
• Hospitalization in the 30 days prior to study enrollment
• Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
• Malignancy
• Chronic infection (HIV, hep B/C, etc.)
• Heavy drinking
• On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
• Recent weight loss (\>5% in the last 2 months)

Sponsors & Collaborators

• University of Oklahoma: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73003, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation; Obesity; Metabolic Syndrome

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 20, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)