[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07417891":3,"trial-entities:NCT07417891":107,"trial-summary:NCT07417891":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":26,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":43,"secondary_outcomes":59,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":14,"eligibility_criteria":69,"std_ages":84,"locations":87,"central_contacts":102,"overall_officials":104,"references":105,"see_also_links":106},"NCT07417891","KDROPMCI","Ketogenic Diet to Reduce Osteoarthritis Pain in MCI","NOT_YET_RECRUITING","2027-06-01","2026-04","2026-05-04","2026-06-01","University of Kansas Medical Center","OTHER",false,"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.","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.\n\nIn 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.\n\nThe 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.\n\nPreclinical 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.\n\nThis 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\u002Finstitutionalization.\n\nUnderstanding 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.",[18,19,20,21,22,23,24,25],"Osteoarthritis (OA) of the Hip","Osteoarthritis (OA) of the Knee","Osteoarthritis (OA) of the Shoulder","Osteoarthritis","Mild Cognitive Impairment","MCI","Mild Cognitive Impairment (MCI)","Dementia",[27,28,29,30],"ketogenic diet","chronic pain","osteoarthritis","mild cognitive impairment","INTERVENTIONAL","TREATMENT",[34],"NA",{"count":36,"type":37},10,"ESTIMATED",[39],{"type":13,"name":40,"description":41,"armGroupLabels":42},"Well-formulated ketogenic diet","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\u002F4 cup of berries per day, daily intake of nuts\u002Fseeds, fatty fish 2-3 times per week, and an emphasis on healthy fats like avocado, nuts, and olive oil.",[40],[44,48,52,56],{"measure":45,"description":46,"timeFrame":47},"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",{"measure":49,"description":50,"timeFrame":51},"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",{"measure":53,"description":54,"timeFrame":55},"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.",{"measure":57,"description":58,"timeFrame":55},"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.",[60,63],{"measure":61,"description":62,"timeFrame":55},"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.",{"measure":64,"description":65,"timeFrame":55},"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\u002FL or higher.","ALL","55 Years","75 Years",{"inclusion":70,"exclusion":74,"raw_text":83},[71,72,73],"English speaking","Diagnosis of major joint osteoarthritis","Diagnosis of mild cognitive impairment",[75,76,77,78,79,80,81,82],"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","Inclusion Criteria:\n\n* English speaking\n* Diagnosis of major joint osteoarthritis\n* Diagnosis of mild cognitive impairment\n\nExclusion Criteria:\n\n* Diabetes that requires insulin\n* Cancer requiring chemo- or radiation therapy in the last 2 years\n* Cardiac event within 1 year\n* Recent history of renal stones\n* Diagnosis of fibromyalgia\n* Already following a ketogenic diet\n* Following a dietary pattern that does not allow for a ketogenic approach\n* Unable to control one's diet",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":12,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"Fairway","Kansas","66205","United States",[94],{"name":95,"role":96,"phone":97,"email":98},"Jessica Keller, PhD, RDN","CONTACT","913-609-5915","jkeller8@kumc.edu",{"lat":100,"lon":101},39.02223,-94.6319,[103],{"name":95,"role":96,"phone":97,"email":98},[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109,21],"Mild cognitive disorder",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.","completed","Ketogenic Diet for Osteoarthritis Pain and Mild Cognitive Impairment","This study is exploring whether a special eating plan called a well-formulated ketogenic diet can help reduce pain from osteoarthritis (OA) in your hip, knee, or shoulder, especially if you also have mild cognitive impairment (MCI). The ketogenic diet is a very low-carbohydrate, higher-fat diet that focuses on whole, nutrient-dense foods. Researchers believe that OA and MCI share similar underlying problems with inflammation and metabolism, and this diet might help by addressing these shared issues. The study will measure changes in your pain intensity, how pain affects your daily life, your overall health-related quality of life, and your physical function over 8 weeks. To join, you need to be between 55 and 75 years old, speak English, and have a diagnosis of both major joint osteoarthritis and mild cognitive impairment. You cannot participate if you have insulin-dependent diabetes, recent cancer treatment, a recent heart event, kidney stones, fibromyalgia, or are already on a ketogenic diet.","Your pain intensity, quality of life, and physical function will be measured from enrollment to the end of treatment at 8 weeks.",155,"You would follow a supervised ketogenic diet for 8 weeks. Assessments will be conducted at the beginning and end of this 8-week period.","Not stated in the trial record.",[40],"v2"]