[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521924":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":46,"centralContacts":50,"locations":60,"responsibleParty":79,"collaborators":32,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":32,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":32,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":63,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic Diet Arm","EXPERIMENTAL","The goal of the KD is to have participants achieve consistent blood BHB ≥0.5 mM; preferably in the range of \\>1 to 3 mM. We will measure ketones daily via finger stick to provide individual feedback and provide a quantitative measure of compliance. The KD will consist of approximately 50 g carbohydrate and 1.5 g\u002Fkg reference weight protein. These may be adjusted based on daily BHB readings. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods. A wide range of foods will be incorporated including non-starchy vegetables, fruits (berries, olives, tomatoes, lemons\u002Flimes), meats (beef, chicken, pork, fish, lamb), nuts and seeds, oils (olive, canola, coconut), cheese, butter, cream, eggs, and fatty fish (salmon, sardines). Nutritional ketosis is associated with natriuresis that will lead to sodium and fluid loss if the extra sodium excreted is not compensated, thus slightly higher sodium and potassium intakes will be required.",[13],"Other: Ketogenic Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Mediterranean Diet + Placebo","PLACEBO_COMPARATOR","The MD+PL arm will be modeled after a Mediterranean style eating pattern. It will contain the same amount of protein as the KD, but with slight variations in protein sources, including limiting red meat to 1x\u002Fwk. The diet will provide unprocessed, higher-fiber foods with emphasis on vegetables, fruits, nuts and seeds, legumes, tubers, whole grains, and fish and seafood. Poultry, eggs, cheese, and yogurt will be included in moderate amounts. Use of olive oil and other monounsaturated fat sources (e.g., avocados and olives) will be encouraged while keeping added sugars to a minimum and avoiding highly processed foods (refined grains, fruit juice, processed meats). Saturated fat will be \\\u003C10% of energy. We will include adequate omega-3 fats (e.g., salmon). No alcohol will be included in both diets, but we will track consumption. This group will also consume two daily doses of placebo.",[19,20],"Other: Mediterranean Intervention","Dietary Supplement: Placebo",{"label":22,"type":23,"description":24,"interventionNames":25},"Mediterranean Diet + Ketone Ester","ACTIVE_COMPARATOR","The MD+KE arm will consume the exact same diet as the MD+PL group with the exception they will consume two daily doses of KE instead of the placebo.",[19,26],"Dietary Supplement: Ketone Ester",[28,33,37,42],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ketogenic Intervention","Participants will receive ready-to-eat Ketogenic Diet meals.",[9],null,{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Mediterranean Intervention","Participants will receive ready-to-eat Mediterranean Diet meals.",[22,15],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"DIETARY_SUPPLEMENT","Placebo","Participants will receive twice-daily placebo servings to be consumed once in the morning and once before sleep.",[15],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"Ketone Ester","Participants will receive twice-daily ketone ester servings to be consumed once in the morning and once before sleep.",[22],[47],{"name":48,"affiliation":5,"role":49},"Jeff S Volek, PhD","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Jeff S Volek, PhD, RD","CONTACT","6146881701","volek.1@osu.edu",{"name":57,"role":53,"phone":58,"phoneExt":32,"email":59},"Madison L Kackley, PhD","7408171622","kackley.19@osu.edu",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The Ohio State University","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-82.99879,39.96118,{"lat":73,"lon":72},[76,78],{"name":48,"role":53,"phone":77,"phoneExt":32,"email":55},"614-688-1701",{"name":57,"role":53,"phone":58,"phoneExt":32,"email":59},{"type":80,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100521924","ketone-conferred-resiliency-against-sleep-restriction-with-nutritional-intervention-100521924",false,"NCT06075914","Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.","Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention (STAK - Sleep + Feed)","Inclusion Criteria:\n\n* Healthy, 18-40 years old.\n* BMI: 20-35 kg\u002Fm2\n* Sleep at least 7h per night.\n* Willing to participate in \\~9-weeks of testing and provided food.\n* Willing to adhere to all study procedures.\n\nExclusion Criteria:\n\n* \\\u003C18 or \\>40 years of age\n* \\>35 body mass index (BMI).\n* Diagnosed sleeping disorders (i.e., sleep apnea, insomnia).\n* Gastrointestinal disorders or food allergies that would interfere with consuming the study supplements.\n* Drink alcohol in excess of 3 drinks\u002Fday or 14 drinks\u002Fweek\n* Have any conditions or contraindications to blood draws.\n* Have been diagnosed with diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or use diabetic medications other than metformin\n* Currently consume a low carbohydrate or ketogenic diet or have done so in the last 3 months\n* Have experienced weight loss of \\>10% of your body weight within the last 6 months\n* Are pregnant, lactating, or planning on becoming pregnant during the study\n* Have any major psychiatric disorders (e.g., schizophrenia, bipolar disorder)",true,"ALL","18 Years","40 Years",{"count":93,"type":94},60,"ESTIMATED","INTERVENTIONAL",[97],"NA","Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. Ketones are small molecules that appear in the blood when following a ketogenic diet or consuming ketone supplements. The goal of this project is to find out if diet and\u002For ketones can improve sleep deprivation detriments over 5 days of sleep restriction (-50% from habitual sleep).",[100,101],"Sleep Deprivation","Nutritional Intervention",[103,104,105,39],"Ketogenic Diet","Mediterranean Diet","Ketone Esters","2026-06-23",{"date":108,"type":109},"2026-06-24","ACTUAL",{"date":111,"type":109},"2023-05-01",{"date":113,"type":94},"2027-02",{"name":5,"class":6},1]