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.
English speaking
Diagnosis of major joint osteoarthritis
Diagnosis of mild cognitive impairment
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
Single group
Well-formulated ketogenic diet
Other interventionThis 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.
Pain intensity and pain interference using a Visual Analog Scale
Patient- and caregiver-reported outcome. 0-10 with higher scores reflecting worse pain.
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.
Physical Function via Functional Activities Questionnaire
Caregiver-reported outcome. FAQ is 0-30 with higher scores indicating worse impairment.
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.
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.
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.
Exploratory: Characterize ketogenic diet-induced changes in the gut
* Stool microbiome profiling * Alpha diversity (Observed species, Shannon, Chao1) * Beta diversity (Bray-Curtis, UniFrac) * Differential abundance of taxa associated with inflammation, SCFA production, bile acid metabolism, metabolic health, and neurodegeneration * Functional pathway analyses (PICRUSt2)
Exploratory: Characterize ketogenic diet-induced changes in intraepidermal nerve fiber density
Skin biopsies -Intraepidermal nerve fiber density (IENFD)
Exploratory: immunostaining skin sample for ASC, a marker of NLRP3 inflammasome activation
Marker expression will be reported as percent positive cells and/or immunoreactivity intensity quantified by digital image analysis (arbitrary units of optical density or fluorescence intensity) within defined regions of interest.
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