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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met