Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets.
NCT ID: NCT06449287
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2018-07-05
2019-08-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Ketogenic Diet
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.
Diet
The diet intervention will start after all baseline testing is complete
Blood Draw
Blood samples will be collected biweekly.
Ketone/Glucose Monitoring
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Urine Analysis
24 hour urine collection will be done biweekly.
Neuropsychological Measures - ANAM
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.
Ketogenic Diet + Ketone Salt
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.
Diet
The diet intervention will start after all baseline testing is complete
Blood Draw
Blood samples will be collected biweekly.
Ketone/Glucose Monitoring
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Urine Analysis
24 hour urine collection will be done biweekly.
Neuropsychological Measures - ANAM
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.
Low Fat Diet +Placebo
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.
Diet
The diet intervention will start after all baseline testing is complete
Blood Draw
Blood samples will be collected biweekly.
Ketone/Glucose Monitoring
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Urine Analysis
24 hour urine collection will be done biweekly.
Neuropsychological Measures - ANAM
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.
Interventions
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Diet
The diet intervention will start after all baseline testing is complete
Blood Draw
Blood samples will be collected biweekly.
Ketone/Glucose Monitoring
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Urine Analysis
24 hour urine collection will be done biweekly.
Neuropsychological Measures - ANAM
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Currently consuming a low-carbohydrate diet
* Weight loss of \>10% in past 6 months -Currently pregnant or nursing, or planning to become pregnant during the study
* Major psychiatric disorder (e.g., schizophrenia, bipolar disorder)
* Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
21 Years
65 Years
ALL
Yes
Sponsors
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Ohio State University
OTHER
Responsible Party
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Principal Investigators
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Jeff Volek, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University
Columbus, Ohio, United States
Countries
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References
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Kackley ML, Brownlow ML, Buga A, Crabtree CD, Sapper TN, O'Connor A, Volek JS. The effects of a 6-week controlled, hypocaloric ketogenic diet, with and without exogenous ketone salts, on cognitive performance and mood states in overweight and obese adults. Front Neurosci. 2022 Sep 30;16:971144. doi: 10.3389/fnins.2022.971144. eCollection 2022.
Belany P, Kackley ML, Zhao S, Kluwe B, Buga A, Crabtree CD, Nedungadi D, Kline D, Brock G, Simonetti OP, Volek JS, Joseph JJ. Effects of Hypocaloric Low-Fat, Ketogenic, and Ketogenic and Ketone Supplement Diets on Aldosterone and Renin. J Clin Endocrinol Metab. 2023 Jun 16;108(7):1727-1739. doi: 10.1210/clinem/dgad009.
Buga A, Kackley ML, Crabtree CD, Bedell TN, Robinson BT, Stoner JT, Decker DD, Hyde PN, LaFountain RA, Brownlow ML, O'Connor A, Krishnan D, McElroy CA, Kraemer WJ, Volek JS. Fasting and diurnal blood ketonemia and glycemia responses to a six-week, energy-controlled ketogenic diet, supplemented with racemic R/S-BHB salts. Clin Nutr ESPEN. 2023 Apr;54:277-287. doi: 10.1016/j.clnesp.2023.01.030. Epub 2023 Feb 4.
Other Identifiers
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2017H0395
Identifier Type: -
Identifier Source: org_study_id