Ketogenic Diet in Rheumatoid Arthritis (RA)

Obesity Clinical Trial

— KETORA  

Official title:

Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05799768
• Other study ID #: 2020H0090
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Ketogenic Dieting
• Metabolic Syndrome
• Obesity
• Rheumatoid Arthritis

Intervention

Behavioral:
• Ketogenic diet
Ketogenic diet counseling

Locations

Country	Name	City	State
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Rheumatology Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP	Systemic marker of inflammation	6 weeks
Secondary	DAS28-CRP	RA disease activity measure	6 weeks