Ketogenic Diet in Rheumatoid Arthritis (RA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic diet.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis, Inflammation, Obesity, Ketogenic Dieting. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study
Overview
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
- Behavioral Ketogenic diet
Ketogenic diet counseling
Primary outcome measures
- hsCRP [Time frame: 6 weeks]
Secondary outcome measures (1)
- DAS28-CRP [Time frame: 6 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Oklahoma University Health Sciences Center — Oklahoma City
Identifiers
NCT: NCT05799768 · 2020H0090