KETORA: Ketogenic Diet in Rheumatoid Arthritis (RA)

Sponsor

Ohio State University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05799768

Collaborator

Rheumatology Research Foundation (Other), National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arm

20.6

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Inflammation Obesity Ketogenic Dieting Metabolic Syndrome	Behavioral: Ketogenic diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketogenic diet plan 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.	Behavioral: Ketogenic diet Ketogenic diet counseling

Arm

Intervention/Treatment

Experimental: Ketogenic diet plan

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.

Behavioral: Ketogenic diet

Ketogenic diet counseling

Outcome Measures

Primary Outcome Measures

hsCRP [6 weeks]

Secondary Outcome Measures

DAS28-CRP [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.
On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)

Exclusion Criteria:

Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
Insulin use
Hospitalization in the 30 days prior to study enrollment
Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
Malignancy
Chronic infection (HIV, hep B/C, etc.)
Heavy drinking
On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
Recent weight loss (>5% in the last 2 months)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University
Rheumatology Research Foundation
National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beatriz Hanaoka, Assistant professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT05799768

Other Study ID Numbers:

2020H0090

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Metabolic Syndrome

Inflammation

Study Results

No Results Posted as of Apr 5, 2023