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Ketogenic Diet in Rheumatoid Arthritis (RA) (KETORA)

Primary Purpose

Rheumatoid Arthritis, Inflammation, Obesity

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Oklahoma University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketogenic diet plan

Arm Description

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.

Outcomes

Primary Outcome Measures

hsCRP
Systemic marker of inflammation

Secondary Outcome Measures

DAS28-CRP
RA disease activity measure

Full Information

First Posted
March 23, 2023
Last Updated
September 12, 2023
Sponsor
University of Oklahoma
Collaborators
Rheumatology Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05799768
Brief Title
Ketogenic Diet in Rheumatoid Arthritis (RA)
Acronym
KETORA
Official Title
Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
Collaborators
Rheumatology Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Inflammation, Obesity, Ketogenic Dieting, Metabolic Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic diet plan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ketogenic diet
Intervention Description
Ketogenic diet counseling
Primary Outcome Measure Information:
Title
hsCRP
Description
Systemic marker of inflammation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
DAS28-CRP
Description
RA disease activity measure
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Oklahoma University Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ketogenic Diet in Rheumatoid Arthritis (RA)

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