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Ketogenic Diet for Rheumatoid Arthritis (KETORA Trial)

N/A
Waitlist Available
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA
Be older than 18 years old
Must not have
Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
Malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial studies a ketogenic diet to see if it helps people with rheumatoid arthritis. Diet is supervised, monitored and personalized with support & coaching. Daily progress is tracked with diet records, monitors and assessments. Blood samples & biopsy also taken.

Who is the study for?
This trial is for people with rheumatoid arthritis who've been on stable RA medication for at least 2 months. It's not suitable for those who've recently lost weight, have chronic infections like HIV or hepatitis, use insulin, had cancer, took steroids in the last month (except certain injections), drink heavily, have other inflammatory diseases, uncontrolled conditions like severe liver or lung disease, were hospitalized recently or tried a ketogenic diet/supplements lately.
What is being tested?
The study tests how a strict ketogenic diet affects individuals with rheumatoid arthritis over six weeks. Participants will get personalized dietary guidance and monitor their progress daily using blood ketone/glucose monitors. They'll also complete health questionnaires and undergo body composition assessments as well as checks of their RA symptoms including blood tests and fat biopsies.
What are the potential side effects?
Potential side effects from following a ketogenic diet may include fatigue, headache ('keto flu'), nutrient deficiencies if not properly managed, digestive issues such as constipation due to low fiber intake, bad breath and possible increased cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with rheumatoid arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled illnesses like severe liver, lung, or kidney disease.
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I have been diagnosed with cancer.
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I have a chronic inflammatory or autoimmune condition, but it's not rheumatoid arthritis.
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I have a chronic infection like HIV or hepatitis B/C.
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I use insulin.
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I have lost more than 5% of my weight in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
hsCRP
Secondary study objectives
DAS28-CRP

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketogenic diet planExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketogenic diet
2020
Completed Early Phase 1
~720

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
464 Previous Clinical Trials
91,127 Total Patients Enrolled
2 Trials studying Metabolic Syndrome
72 Patients Enrolled for Metabolic Syndrome
Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,759 Total Patients Enrolled
11 Trials studying Metabolic Syndrome
983 Patients Enrolled for Metabolic Syndrome
Rheumatology Research FoundationOTHER
11 Previous Clinical Trials
8,057 Total Patients Enrolled
~4 spots leftby Dec 2028
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