Ketogenic Diet to Reduce Osteoarthritis Pain in MCI

NCT07417891 | Not Yet Recruiting

• 1 other identifier: KDROPMCI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis and mild cognitive impairment are common conditions that share underlying biological processes related to metabolism and inflammation. This study will examine whether a well-formulated ketogenic diet influences pain, physical function, and cognitive outcomes in adults with osteoarthritis and mild cognitive impairment. Participants will follow a supervised ketogenic dietary intervention, with assessments conducted before and after the intervention to evaluate changes in symptoms and related biological markers. The goal of this study is to better understand shared mechanisms between joint pain and cognitive health and to explore whether a ketogenic dietary approach may support symptom management in these populations.

Conditions

Osteoarthritis (OA) of the Knee; Osteoarthritis; Mild Cognitive Impairment; MCI; Mild Cognitive Impairment (MCI); Dementia; Osteoarthritis (OA) of the Hip; Osteoarthritis (OA) of the Shoulder

Keywords

ketogenic diet; chronic pain; osteoarthritis; mild cognitive impairment

Outcome Measures

Primary Outcomes (4)

• Pain intensity and pain interference using a Visual Analog Scale

  Patient- and caregiver-reported outcome. 0-10 with higher scores reflecting worse pain.

  From enrollment to the end of treatment at 8 weeks

• Health-related quality of life using a Questionnaire

  Patient- and caregiver-reported ouctome.The PROMIS-29+2 Profile is a patient-reported outcome measure with domain scores converted to standardized T-scores (mean = 50, SD = 10), where higher scores indicate worse symptoms for anxiety, depression, fatigue, sleep disturbance, and pain interference, better functioning for physical function, social participation, and cognitive function, and pain intensity is rated separately on a 0-10 scale with higher scores indicating greater pain.

  From enrollment to end of treatment at 8 weeks

• Physical Function via Functional Activities Questionnaire

  Caregiver-reported outcome. FAQ is 0-30 with higher scores indicating worse impairment.

  From enrollment to end of treatment at 8 weeks.

• Montreal Cognitive Assessment (MoCA) for brief global cognitive screening

  Cognitive screener completed by the participant and administered by the study coordinator. The Montreal Cognitive Assessment (MoCA) is a 30-point cognitive screening tool assessing multiple cognitive domains, with total scores ranging from 0 to 30 and higher scores indicating better cognitive function.

  From enrollment to end of treatment at 8 weeks.

Secondary Outcomes (2)

• Central sensitization

  From enrollment to end of treatment at 8 weeks.

• Ketone levels

  From enrollment to end of treatment at 8 weeks.

Other Outcomes (3)

• Exploratory: Characterize ketogenic diet-induced changes in the gut

  From enrollment to end of treatment at 8 weeks.

• Exploratory: Characterize ketogenic diet-induced changes in intraepidermal nerve fiber density

  From enrollment to end of treatment at 8 weeks.

• Exploratory: immunostaining skin sample for ASC, a marker of NLRP3 inflammasome activation

  From enrollment to end of the 8 weeks.

Study Arms (1)

Well-formulated ketogenic diet

EXPERIMENTAL

This is a dietary intervention that is very low carbohydrate, higher healthy fats, and adequate protein.

Other: Well-formulated ketogenic diet

Interventions

Well-formulated ketogenic diet OTHER

This is a very low carbohydrate eating pattern that is higher in fat with adequate protein. This approach focuses on a nutrient dense, whole foods approach to a ketogenic diet and recommends 4-6 servings of non-starchy vegetables per day, 1/4 cup of berries per day, daily intake of nuts/seeds, fatty fish 2-3 times per week, and an emphasis on healthy fats like avocado, nuts, and olive oil.

Well-formulated ketogenic diet

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Diagnosis of major joint osteoarthritis
• Diagnosis of mild cognitive impairment

You may not qualify if:

• Diabetes that requires insulin
• Cancer requiring chemo- or radiation therapy in the last 2 years
• Cardiac event within 1 year
• Recent history of renal stones
• Diagnosis of fibromyalgia
• Already following a ketogenic diet
• Following a dietary pattern that does not allow for a ketogenic approach
• Unable to control one's diet

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Cognitive Dysfunction; Dementia; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica Keller, PhD, RDN

CONTACT

913-609-5915; jkeller8@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair of Research, Department of Anesthesiology

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)