Osteoarthritis (OA) of the HipKDROP-MCINCT07417891
Ketogenic Diet to Reduce Osteoarthritis Pain in MCI
A study testing Well-formulated ketogenic diet in people with Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Osteoarthritis (OA) of the Shoulder
- What is being tested?
- Well-formulated ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Diagnosis of major joint osteoarthritis
- Diagnosis of mild cognitive impairment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kansas Medical Center
Fairway, Kansas, 66205
Jessica Keller, PhD, RDN, 913-609-5915, jkeller8@kumc.edu
About this study
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.
Read the detailed description
OA and dementia are two leading contributors to disability worldwide. Although traditionally studied separately, accumulating evidence indicates substantial overlap in their underlying inflammatory, metabolic, and neuroimmune pathways. Chronic OA pain is associated with systemic inflammatory mediators, increased peripheral nociceptor sensitization, impaired descending inhibition, and central neuroinflammation driven by microglia and astrocyte activation. These same mechanisms contribute to cognitive decline, reduced synaptic plasticity, hippocampal vulnerability, and progression from MCI to ADRD.
In aging adults, chronic pain accelerates cognitive decline and increases risk for dementia, and cognitive impairment exacerbates pain-related disability. Neuroinflammation-particularly microglial activation and NLRP3 inflammasome signaling-is a shared mechanistic link between the two conditions. Identifying interventions that target this shared biology is crucial for improving outcomes for older adults with comorbid pain and cognitive decline.
The ketogenic diet has demonstrated therapeutic effects in multiple neurological, metabolic, and inflammatory conditions. Mechanisms include suppression of the NLRP3 inflammasome, improved mitochondrial efficiency, enhanced lipid metabolism via TREM2-associated pathways, reduced oxidative stress, reduced systemic inflammation, glycemic control, and modulation of gut microbiota.
Preclinical data show that ketone bodies improve cognitive function and reduce neuroinflammation in models of AD. Human studies demonstrate the feasibility and potential cognitive benefit of WFKD in ADRD populations and post-concussion syndrome. Additionally, this study team recently investigated the impact of an 8-week WFKD on modifiable risk factors associated with metabolic syndrome, on gut microbiota structure, and RNASeq in healthy, middle-aged adults. However, the application of a WFKD to individuals with OA and early cognitive impairment is unexplored. Our team has conducted two previous clinical trials and is currently analyzing outcomes of an NIA-funded clinical trial using the WFKD. Participants from these trials have successfully adopted the WFKD, evidenced by objective and reported ketone body production and macronutrient profile of dietary intake. The WFKD used in these trials improved micronutrient intake and intake of non-starchy vegetables, and suggests that the WFKD may benefit cognition in patients with AD and symptoms in patients with post-concussion syndrome.
This population is particularly relevant given the aging US population, the high prevalence of OA-associated chronic pain, the presence of early neuroinflammation and neurodegeneration, poor diet quality contributing to systemic inflammation, and heightened vulnerability to cognitive decline, reduced quality of life, and hospitalization/institutionalization.
Understanding how a WFKD influences pain, neuroinflammation, central sensitization, cognitive performance, and biologic indicators from the gut and peripheral nerves will provide critical insight into mechanistic targets for future clinical trials.
- Conditions
- Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Osteoarthritis (OA) of the Shoulder, Osteoarthritis, Mild Cognitive Impairment, MCI
- Being tested
- Well-formulated ketogenic diet
- Keywords
- ketogenic diet, chronic pain, osteoarthritis, mild cognitive impairment
- Medical subject headings
- Osteoarthritis, Cognitive Dysfunction, Dementia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-formulated ketogenic dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Well-formulated ketogenic diet | Experimental | This is a dietary intervention that is very low carbohydrate, higher healthy fats, and adequate protein. Receives: Other: Well-formulated ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity and pain interference using a Visual Analog Scale
Patient- and caregiver-reported outcome. 0-10 with higher scores reflecting worse pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 8 weeks.
Secondary outcomes (2)
Central sensitization
Physical assessment of the participant. Temporal summation is a quantitative sensory testing measure of central sensitization calculated as the increase in reported pain intensity following repeated identical stimuli, with higher values indicating greater pain facilitation.
Measured: From enrollment to end of treatment at 8 weeks.
Ketone levels
We will run a correlational analysis on depth of ketosis and change in pain intensity. We will consider 'nutritional ketosis' as 0.5 mmol/L or higher.
Measured: From enrollment to end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doug Wright, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417891
- Sponsor's protocol ID
- KDROPMCI
- Acronym
- KDROP-MCI
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet to Reduce Osteoarthritis Pain in MCI
- ClinicalTrials.gov ID
- NCT07417891
- Acronym / sponsor ID
- KDROP-MCI / KDROPMCI
- Conditions
- Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Osteoarthritis (OA) of the Shoulder, Osteoarthritis, Mild Cognitive Impairment, MCI
- Keywords
- ketogenic diet, chronic pain, osteoarthritis, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OA and dementia are two leading contributors to disability worldwide. Although traditionally studied separately, accumulating evidence indicates substantial overlap in their underlying inflammatory, metabolic, and neuroimmune pathways. Chronic OA pain is associated with systemic inflammatory mediators, increased peripheral nociceptor sensitization, impaired descending inhibition, and central neuroinflammation driven by microglia and astrocyte activation. These same mechanisms contribute to cognitive decline, reduced synaptic plasticity, hippocampal vulnerability, and progression from MCI to ADRD.
In aging adults, chronic pain accelerates cognitive decline and increases risk for dementia, and cognitive impairment exacerbates pain-related disability. Neuroinflammation-particularly microglial activation and NLRP3 inflammasome signaling-is a shared mechanistic link between the two conditions. Identifying interventions that target this shared biology is crucial for improving outcomes for older adults with comorbid pain and cognitive decline.
The ketogenic diet has demonstrated therapeutic effects in multiple neurological, metabolic, and inflammatory conditions. Mechanisms include suppression of the NLRP3 inflammasome, improved mitochondrial efficiency, enhanced lipid metabolism via TREM2-associated pathways, reduced oxidative stress, reduced systemic inflammation, glycemic control, and modulation of gut microbiota.
Preclinical data show that ketone bodies improve cognitive function and reduce neuroinflammation in models of AD. Human studies demonstrate the feasibility and potential cognitive benefit of WFKD in ADRD populations and post-concussion syndrome. Additionally, this study team recently investigated the impact of an 8-week WFKD on modifiable risk factors associated with metabolic syndrome, on gut microbiota structure, and RNASeq in healthy, middle-aged adults. However, the application of a WFKD to individuals with OA and early cognitive impairment is unexplored. Our team has conducted two previous clinical trials and is currently analyzing outcomes of an NIA-funded clinical trial using the WFKD. Participants from these trials have successfully adopted the WFKD, evidenced by objective and reported ketone body production and macronutrient profile of dietary intake. The WFKD used in these trials improved micronutrient intake and intake of non-starchy vegetables, and suggests that the WFKD may benefit cognition in patients with AD and symptoms in patients with post-concussion syndrome.
This population is particularly relevant given the aging US population, the high prevalence of OA-associated chronic pain, the presence of early neuroinflammation and neurodegeneration, poor diet quality contributing to systemic inflammation, and heightened vulnerability to cognitive decline, reduced quality of life, and hospitalization/institutionalization.
Understanding how a WFKD influences pain, neuroinflammation, central sensitization, cognitive performance, and biologic indicators from the gut and peripheral nerves will provide critical insight into mechanistic targets for future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Well-formulated ketogenic diet | Experimental | Other: Well-formulated ketogenic dietThis is a dietary intervention that is very low carbohydrate, higher healthy fats, and adequate protein. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Diagnosis of major joint osteoarthritis
- Diagnosis of mild cognitive impairment
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-formulated ketogenic dietThis 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. | Other | Well-formulated ketogenic diet |
Primary outcome
Pain intensity and pain interference using a Visual Analog Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Patient- and caregiver-reported outcome. 0-10 with higher scores reflecting worse pain.
Health-related quality of life using a Questionnaire
Time frame: From enrollment to end of treatment at 8 weeks
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.
Physical Function via Functional Activities Questionnaire
Time frame: From enrollment to end of treatment at 8 weeks.
Caregiver-reported outcome. FAQ is 0-30 with higher scores indicating worse impairment.
Montreal Cognitive Assessment (MoCA) for brief global cognitive screening
Time frame: From enrollment to end of treatment at 8 weeks.
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.
2 secondary outcomes
Central sensitization
Time frame: From enrollment to end of treatment at 8 weeks.
Ketone levels
Time frame: From enrollment to end of treatment at 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-formulated ketogenic diet in people with Osteoarthritis (OA) of the Hip and Osteoarthritis (OA) of the Knee, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Keller, PhD, RDN (913-609-5915, jkeller8@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity and pain interference using a Visual Analog Scale (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.