NCT05799768Enrolling by invitation
Ketogenic Diet in Rheumatoid Arthritis (RA)
Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study
Source: ClinicalTrials.gov · Last updated 7 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 23 Mar 2023
- Start date
- 20 Apr 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Oklahoma
- Diseases
- Obesity, Rheumatoid arthritis
- NCT number
- NCT05799768
What you commit to
- Study type: Interventional
- Planned participants: 6
- From 20 Apr 2023 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalization in the 30 days prior to study enrollment
- On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
Other illness
- Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
- Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
- Malignancy
- Chronic infection (HIV, hep B/C, etc.)
Other
- Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
- Insulin use
- Heavy drinking
- Recent weight loss (\>5% in the last 2 months)
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oklahoma University Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.