An interventional study of Diet and Blood Draw in Ketogenic Diet and Weight Loss, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Ohio State University · Not applicable, Interventional, and Basic science
This project will be a three-group controlled 6-wk feeding study where all meals are prepared and provided to obese participants. All participants will be fed a 25% energy-restricted diet. Two diets will be very low in carbohydrate (i.e., ketogenic diets) designed to induce nutritional ketosis and fat loss. Another diet will be low in fat and saturated fat but contain the same total calories. Participants will be randomly assigned to a Ketone Supplement group who are provided an exogenous pre-formed source of beta-hydroxybutyrate (BOHB) or a Control group that only receives the standard ketogenic diet. Randomization will be stratified based on insulin resistance, sex, and body composition to ensure balanced group assignment. Because of timing of recruitment (i.e., after most of the ketogenic groups have already completed the study), the low-fat group will not be randomized. Outcome measurements will be made at various intervals over the 6-wk intervention.
This project will be a three-group controlled 6-wk feeding study where all meals are prepared and provided to obese participants. All participants will be fed a 25% energy-restricted diet. Two diets will be very low in carbohydrate (i.e., ketogenic diets) designed to induce nutritional ketosis and fat loss. Another diet will be low in fat and saturated fat but contain the same total calories. Participants will be randomly assigned to a Ketone Supplement group (n=12) who are provided an exogenous pre-formed source of beta-hydroxybutyrate (BOHB) or a Control group (n=12) that only receives the standard ketogenic diet. Randomization will be stratified based on insulin resistance, sex, and body composition to ensure balanced group assignment. Because of timing of recruitment (i.e., after most of the ketogenic groups have already completed the study), the low-fat group will not be randomized. Outcome measurements will be made at various intervals over the 6-wk intervention. Key outcome variables will include: 1) Markers of Ketosis/Keto-Adaptation: a. Daily measures of BOHB (capillary blood) b. Fasting serum BOHB and total ketones (venous blood) c. Diurnal capillary blood ketones and urinary loss of BOHB and total ketones 2) Energy Balance and Body Composition: a. Body mass (scale) b. Whole body and regional composition (DXA) c. Nitrogen balance (daily nitrogen intake - 24-hr urinary nitrogen loss) d. Resting energy expenditure and substrate oxidation (indirect calorimetry) e. Adiposity (myocardial/epicardial fat, liver fat, visceral fat, skeletal muscle fat by MRI) f. Microbiome (stool collection to observe microbiota and the response to diet alteration) 3) Cognitive and Behavioral: a. Computer-based cognitive function (ANAM) b. Behavioral responses (surveys) 4) Cardio-Metabolic Risk: a. Metabolic panel b. Circulating lipid panel (total cholesterol, LDL-C, HDL-C, TG) c. Glucose, insulin, HOMA
1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.
This study's enrollment of 37 is below the median of 73 across 1,540 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will have all their meals prepared in the Instructional Kitchen in the Ohio Union, irrespective of group assignment. They will receive a daily caloric intake equal to 75% of their estimated requirement to maintain weight, which should result in weight loss over the 6-week period. For those in the ketogenic groups, daily macronutrient intake will consist of 35 g of carbohydrates and moderate protein calculated as 1.5 g/kg of reference weight. The remaining caloric intake will consist of fat. A wide range of whole foods will be incorporated into the meals, including non-starchy vegetables, meats, nuts and seeds, oils, cheese, butter, cream, and eggs. The menu will be shared with participants prior to enrolling in the study so they know what to expect in terms of the meal plans.
Other: Diet · Biological: Blood Draw · Biological: Ketone/Glucose Monitoring · Other: Body Composition · Biological: Urine Analysis · Behavioral: Neuropsychological Measures - ANAM
Participants will have all their meals prepared in the Instructional Kitchen in the Ohio Union, irrespective of group assignment. They will receive a daily caloric intake equal to 75% of their estimated requirement to maintain weight, which should result in weight loss over the 6-week period. For those in the ketogenic groups, daily macronutrient intake will consist of 35 g of carbohydrates and moderate protein calculated as 1.5 g/kg of reference weight. The remaining caloric intake will consist of fat. A wide range of whole foods will be incorporated into the meals, including non-starchy vegetables, meats, nuts and seeds, oils, cheese, butter, cream, and eggs. The menu will be shared with participants prior to enrolling in the study so they know what to expect in terms of the meal plans. This group will also be provided a ketone salt supplement to take x2 daily.
Other: Diet · Biological: Blood Draw · Biological: Ketone/Glucose Monitoring · Other: Body Composition · Biological: Urine Analysis · Behavioral: Neuropsychological Measures - ANAM
The low-fat comparison group will also be provided all their food. Their diet will also be restricted in calories and have the same level of protein, but it will be lower in fat and higher in carbohydrate. The low-fat diet will consist of approximately 25% fat, with the remaining calories coming from carbohydrates (approximately 55% after accounting for protein at around 20%). Added sugars will be kept relatively low (less than 25 g/day) with a focus on unprocessed carbohydrate-rich foods. Saturated fat will be limited to less than 10% of total energy, with a focus on unsaturated fat sources.
Other: Diet · Biological: Blood Draw · Biological: Ketone/Glucose Monitoring · Other: Body Composition · Biological: Urine Analysis · Behavioral: Neuropsychological Measures - ANAM
The diet intervention will start after all baseline testing is complete
Blood samples will be collected biweekly.
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
DEXA Scanning will be done pre-, mid-, and post- intervention.
24 hour urine collection will be done biweekly.
The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). This cognitive battery is a library of computer-based tests of domains including attention, concentration, reaction time, memory, processing speed, decision-making, and executive function.
Daily Ketone/Glucose Monitoring
Daily fasting glucose/ketones will be assessed using capillary finger stick lancing. A small drop of blood will be obtained once daily, while fasting, using enzymatic strips fitted for a handheld analyzer (KetoMojo). All the data will be stored in the device's internal memory.
Time frame: Up to 6 weeks
Cholesterol (mg/dl)
Fasting venous blood will be collected biweekly to measure cholesterol.
Time frame: up to six weeks
Insulin (mIU/L)
Fasting venous blood will be collected biweekly.
Time frame: up to six weeks
Glucose (mg/dL)
Fasting venous blood will be collected biweekly.
Time frame: up to six weeks
Lean Mass (kg)
DEXA Scanning will be biweekly to assess lean mass
Time frame: up to six weeks
Fat Mass (kg)
DEXA Scanning will be biweekly to assess fat mass
Time frame: up to six weeks
Neuropsychological Outcome 1 - Reaction time (Throughput)
The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). Measures SRT by presenting the user with a series of "\*" symbols to which they must respond as quickly as possible each time the symbol appears. Results are measured by throughput.
Time frame: up to six weeks
Neuropsychological Outcome 1 - Visual Short Term Memory (Throughput)
The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). Measures verbal short-term memory by having the users memorize a set of characters and then indicate as single characters are presented on the screen whether the character was part of the memory set. Results are measured by throughput.
Time frame: up to six weeks
Neuropsychological Outcome 1 - Spatial Processing (Throughput)
The first cognitive assessment will be done via Automated Neuropsychological Assessment Metrics (ANAM). Measures visual spatial skills and mental rotation by having the users compare the equivalence of two 4-bar histograms, the first of which is displayed upright and the second of which is displayed after a 90° rotation either clockwise or counterclockwise. Results are measured by Throughput.
Time frame: up to six weeks
Urine Chemistries
24 hour urine will be collected biweekly and analyzed for urine chemistries
Time frame: up to 6 weeks
Plan to share: No
Ran from Jul 2018 to primary completion in Mar 2019, 7 months.
Of 681 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 7 months is below that.
Counting every sponsor, half of 736 studies reached it within 22 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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