← Back to Search

Other

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

KETORA Trial 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.Check my eligibility

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.See study design

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.

KETORA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with rheumatoid arthritis.

KETORA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

hsCRP

Secondary outcome measures

DAS28-CRP

KETORA 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

N/A

~680

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,604 Total Patients Enrolled

2 Trials studying Metabolic Syndrome

93 Patients Enrolled for Metabolic Syndrome

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,737 Total Patients Enrolled

11 Trials studying Metabolic Syndrome

983 Patients Enrolled for Metabolic Syndrome

Rheumatology Research FoundationOTHER

9 Previous Clinical Trials

7,365 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do any of the participants for this trial have to be younger than 45 years old?

"The criteria for inclusion in this trial necessitates that participants are 18 years of age or older and younger than 65."

Answered by AI

Does this clinical trial offer the opportunity for enrollment?

"In order to be eligible for this trial, participants must present with evidence of inflammation and fall into the age bracket of 18-65. The study is seeking a total of 6 qualified candidates."

Answered by AI

Are participants currently being sought for this investigation?

"Clinicaltrials.gov confirms that this medical trial, which was initially listed on April 15th 2023, is not currently seeking participants. Nevertheless, there are over 1800 other clinical trials actively recruiting patients as of today's date."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketogenic Diet in Rheumatoid Arthritis (RA)

Beatriz Hanaoka 2023. "Ketogenic Diet in Rheumatoid Arthritis (RA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05799768.

All > Metabolic Syndrome > Ra