Ketogenic Diet for Rheumatoid Arthritis

(KETORA Trial)

Enrolling by invitation at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Oklahoma
Must be taking: Dmards, Biological agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a ketogenic diet (a high-fat, low-carb eating plan) might benefit people with rheumatoid arthritis, an autoimmune condition that causes joint pain. Participants will receive personalized coaching and support from a dietitian to adhere to the diet plan. Blood tests and diet records will track daily progress, along with additional health assessments. The trial seeks individuals with rheumatoid arthritis who are currently on stable medication doses. As an unphased trial, participants can contribute to groundbreaking research that may provide new dietary insights for managing rheumatoid arthritis.

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 prior data suggests that this ketogenic diet is safe for individuals with rheumatoid arthritis?

Studies have shown that the ketogenic diet (KD) can alter health indicators. For instance, it can raise both LDL and HDL cholesterol levels, which are types of fats in the blood. Some individuals might also experience weight loss and reduced body fat. However, the diet's very low carbohydrate content can be challenging for some.

Regarding safety, the ketogenic diet is generally safe for most people when followed correctly. Most issues arise during the initial adjustment period, often called the "keto flu," which can include headaches, tiredness, and nausea. These symptoms usually disappear after a few days. Long-term research on its safety for people with rheumatoid arthritis is ongoing, so it's important to monitor possible changes in cholesterol or other health indicators.

Overall, while the ketogenic diet has been used for various conditions and many people tolerate it well, discussing it with a healthcare provider is always advisable, especially when managing a condition like rheumatoid arthritis.12345

Why are researchers excited about this trial?

Researchers are excited about using a ketogenic diet for rheumatoid arthritis because it offers a non-drug approach to managing the condition. Traditional treatments like NSAIDs, corticosteroids, and DMARDs focus on reducing inflammation and suppressing the immune system. In contrast, the ketogenic diet aims to alter metabolism by promoting a state of ketosis, which may reduce inflammation and pain naturally. This diet also provides personalized support and continuous monitoring, potentially leading to better adherence and outcomes compared to standard medication regimens.

What evidence suggests that the ketogenic diet might be an effective treatment for rheumatoid arthritis?

Research has shown that a ketogenic diet (KD) might help reduce inflammation in people with rheumatoid arthritis (RA). This diet is high in fats and low in carbohydrates. In this trial, participants will follow a ketogenic diet plan, receiving extensive educational and ongoing support. One study found that a ketogenic diet can lower inflammation, potentially easing RA symptoms. Another study found that people on a low-carbohydrate ketogenic diet lost more fat than those on a low-fat diet. This weight loss could also help reduce RA symptoms by relieving pressure on the joints. While more research is needed, these early findings suggest that the KD might be helpful for RA due to its anti-inflammatory effects.16789

Are You a Good Fit for This Trial?

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
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ketogenic diet planExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

The Effect of Ketogenic Diet on Inflammatory Arthritis and ...A meta-analysis of 53 studies including 68.128 participants suggested that higher-fat, low-carbohydrate diet, was the best intervention to achieve the weight ...
Ketogenic diet ameliorates inflammation by inhibiting the ...The ketogenic diet (KD), a high-fat, low-carbohydrate diet with adequate proteins, has been used to treat intractable epilepsy since 1921.
AB0444 VERY LOW-CALORIE KETOGENIC DIET IN ...The very low-calorie ketogenic diet (VLCKD) is characterized by a restrictive dietary plan, low in carbohydrates and high in fat.
The effect of low-carbohydrate ketogenic diet in ...LCKD group showed a significant reduction of 4.0% (95% CI: 3.3–4.7) in fat mass, compared to 1.4% (95% CI: 0.83–1.9) in the LCLF group with p-value<0.001. In ...
Effect of Anti-Inflammatory Diets on Pain in Rheumatoid ...Effects of a Very Low-Fat, Vegan Diet in Subjects with Rheumatoid Arthritis. J. Altern. Complement. Med. 2002, 8, 71–75. [Google Scholar] [CrossRef] [PubMed] ...
Ketogenic Diet and Multiple Health Outcomes: An Umbrella ...For a low-carbohydrate, high-fat diet, is generally associated with higher concentrations of LDL and HDL cholesterol and lower serum ...
Effects of ketogenic diet on health outcomes: an umbrella ...The KD eating pattern severely restricts carbohydrate intake to less than 50 g/day while increasing protein and fat intake [3,4,5,6].
Invited Review Article Ketogenic diet and cardiovascular riskAnother meta-analysis of 18 trials revealed a significant reduction in body mass, BMI, fat mass, percentage body fat, visceral adipose tissue, fat-free mass, ...
Efficacy, Safety, and Tolerability of a Very Low-Calorie ...Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: The FEAST randomised controlled trial protocol. BMJ Open 2024, 14 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security