Ketogenic Diet in Rheumatoid Arthritis (RA)

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05799768
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic diet — BEHAVIORAL
    Ketogenic diet counseling

Study Details

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.

Key Dates

Start date
Apr 20, 2023
Status verified
Feb 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

hsCRP [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Oklahoma University Health Sciences CenterOklahoma CityOklahoma73003-

Find similar trials in Oklahoma City, OK

By condition
Obesity / overweightRheumatoid arthritis
By specialty
EndocrinologyMetabolic healthWeight lossRheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Oklahoma University Health Sciences Center· Oklahoma City, OK

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