Ketogenic Diet in Rheumatoid Arthritis (RA)

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

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05799768

Acronym

KETORA

Enrollment

Registered

2023-04-05

Start date

2023-04-20

Completion date

2029-12-31

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALKetogenic diet

Ketogenic diet counseling

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
hsCRP	6 weeks	Systemic marker of inflammation

Secondary

Measure	Time frame	Description
DAS28-CRP	6 weeks	RA disease activity measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026