Ketogenic Diet for Rheumatoid Arthritis

(KETORA Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: Dmards, Biological agents

Must not be taking: Glucocorticoids, Insulin

Disqualifiers: Chronic inflammatory, Autoimmune, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on stable doses of certain RA medications for at least 2 months before joining. It's best to discuss with the trial team or your doctor.

What data supports the effectiveness of the ketogenic diet as a treatment for rheumatoid arthritis?

Research suggests that dietary changes can influence rheumatoid arthritis by reducing inflammation, and while the ketogenic diet specifically hasn't been proven effective, other diets like the Mediterranean diet have shown benefits. The ketogenic diet may help by reducing certain hormones and maintaining immune cell function, which could potentially benefit rheumatoid arthritis patients. ^{1 2 3 4 5}

Is the ketogenic diet safe for humans?

The ketogenic diet, which is high in fats and low in carbohydrates, has been studied for various conditions and is generally considered safe for most people. However, it can lead to changes in hormone levels and may not be suitable for everyone, so it's important to consult with a healthcare provider before starting it. ^{2 3 6 7 8}

How does the ketogenic diet treatment for rheumatoid arthritis differ from other treatments?

The ketogenic diet is unique for rheumatoid arthritis as it focuses on high fat and low carbohydrate intake, which may reduce inflammation by altering hormone levels like leptin and IGF-1, and potentially affecting gut microbiota, unlike traditional diets that emphasize balanced carbohydrate intake. ^{2 3 9 10 11}

Eligibility Criteria

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.

Inclusion Criteria

I have been on stable doses of my arthritis medication for at least 2 months.

I have been diagnosed with rheumatoid arthritis.

Exclusion Criteria

I do not have any uncontrolled illnesses like severe liver, lung, or kidney disease.

I have been diagnosed with cancer.

Hospitalization in the 30 days prior to study enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 6-week ketogenic diet plan, supervised and monitored by a dietician. Diet adherence and progress are assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants receive personalized coaching and support.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of body composition and RA disease activity.

4 weeks

Treatment Details

Interventions

• Ketogenic Diet

Trial Overview 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.

Participant Groups

Group I: Ketogenic diet plan Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Rheumatology Research Foundation

Collaborator

Trials

14

Recruited

8,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a 12-week randomized trial involving 154 overweight and obese patients with rheumatoid arthritis, the Mediterranean diet (MD) significantly reduced disease activity scores (DAS 28) compared to a low-fat high-carbohydrate diet and control group, indicating better management of RA symptoms.

The MD led to a 76% reduction in DAS 28 scores, demonstrating its effectiveness in reducing pain and inflammation in RA patients, regardless of weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Pattern or Weight Loss: Which One Is More Important to Reduce Disease Activity Score in Patients with Rheumatoid Arthritis? A Randomized Feeding Trial. Sadeghi, A., Tabatabaiee, M., Mousavi, MA., et al.[2023]

References

1. Norway pubmed.ncbi.nlm.nih.gov

[Diet and rheumatoid arthritis]. [2008]

2. Italy pubmed.ncbi.nlm.nih.gov

Reduction in serum leptin and IGF-1 but preserved T-lymphocyte numbers and activation after a ketogenic diet in rheumatoid arthritis patients. [2017]

3. India pubmed.ncbi.nlm.nih.gov

Dietary Pattern or Weight Loss: Which One Is More Important to Reduce Disease Activity Score in Patients with Rheumatoid Arthritis? A Randomized Feeding Trial. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Nutrition and its role in prevention and management of rheumatoid arthritis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Diet therapy for rheumatoid arthritis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Diet and rheumatoid arthritis: a review of the literature. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Are there effective dietary recommendations for patients with rheumatoid arthritis?]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Dietary interventions for rheumatoid arthritis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Ideal food pyramid for patients with rheumatoid arthritis: A narrative review. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Potential Benefit of "Balanced Diet" for Rheumatoid Arthritis. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Are we really what we eat? Nutrition and its role in the onset of rheumatoid arthritis. [2018]