Ketogenic DietSTAKNCT06449287
Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets.
A study testing Diet, Blood Draw and Ketone/Glucose Monitoring in people with Ketogenic Diet and Weight Loss, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Diet, Weight Loss
- What is being tested?
- Diet, Blood Draw and Ketone/Glucose Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 21 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >27 and =35 kg/m2
Who cannot join
- have diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or using diabetic medications.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies to Augment Ketosis: Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets.
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.
Read the detailed description
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
- Conditions
- Ketogenic Diet, Weight Loss
- Being tested
- Diet, Blood Draw, Ketone/Glucose Monitoring, Body Composition, Urine Analysis
- Keywords
- ketones, metabolism, weight loss
- Medical subject headings
- Weight Loss, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
The diet intervention will start after all baseline testing is complete
Blood DrawBiological
Blood samples will be collected biweekly.
Ketone/Glucose MonitoringBiological
Hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body CompositionOther
DEXA Scanning will be done pre-, mid-, and post- intervention.
Urine AnalysisBiological
24 hour urine collection will be done biweekly.
Neuropsychological Measures - ANAMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | 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. Receives: Other: Diet; Biological: Blood Draw; Biological: Ketone/Glucose Monitoring; Other: Body Composition; Biological: Urine Analysis; Behavioral: Neuropsychological Measures - ANAM |
| Ketogenic Diet + Ketone Salt | Experimental | 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. Receives: Other: Diet; Biological: Blood Draw; Biological: Ketone/Glucose Monitoring; Other: Body Composition; Biological: Urine Analysis; Behavioral: Neuropsychological Measures - ANAM |
| Low Fat Diet +Placebo | Active comparator | 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. Receives: Other: Diet; Biological: Blood Draw; Biological: Ketone/Glucose Monitoring; Other: Body Composition; Biological: Urine Analysis; Behavioral: Neuropsychological Measures - ANAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Cholesterol (mg/dl)
Fasting venous blood will be collected biweekly to measure cholesterol.
Measured: up to six weeks
Insulin (mIU/L)
Fasting venous blood will be collected biweekly.
Measured: up to six weeks
Glucose (mg/dL)
Fasting venous blood will be collected biweekly.
Measured: up to six weeks
Lean Mass (kg)
DEXA Scanning will be biweekly to assess lean mass
Measured: up to six weeks
Fat Mass (kg)
DEXA Scanning will be biweekly to assess fat mass
Measured: up to six weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: up to six weeks
Urine Chemistries
24 hour urine will be collected biweekly and analyzed for urine chemistries
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start5 Jul 2018
- Primary completion1 Mar 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ketogenic DietStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Volek, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449287
- Sponsor's protocol ID
- 2017H0395
- Acronym
- STAK
- Status last verified
- Dec 2024
- First submitted
- 31 May 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36248655Belany 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.
PubMed 36629058Buga 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.
PubMed 36963874
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Augment Ketosis: Impact of Exogenous Ketones on Indices of Keto-Adaptation in Obese Subjects on Weight Reducing Diets.
- ClinicalTrials.gov ID
- NCT06449287
- Acronym / sponsor ID
- STAK / 2017H0395
- Conditions
- Ketogenic Diet, Weight Loss
- Keywords
- ketones, metabolism, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Diet, Biological: Blood Draw, Biological: Ketone/Glucose Monitoring, Other: Body Composition, Biological: Urine Analysis, Behavioral: Neuropsychological Measures - ANAMParticipants 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. |
| Ketogenic Diet + Ketone Salt | Experimental | Other: Diet, Biological: Blood Draw, Biological: Ketone/Glucose Monitoring, Other: Body Composition, Biological: Urine Analysis, Behavioral: Neuropsychological Measures - ANAMParticipants 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. |
| Low Fat Diet +Placebo | Active comparator | Other: Diet, Biological: Blood Draw, Biological: Ketone/Glucose Monitoring, Other: Body Composition, Biological: Urine Analysis, Behavioral: Neuropsychological Measures - ANAMThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI >27 and =35 kg/m2
Key exclusion criteria (5 listed)
- have diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or using diabetic medications.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietThe diet intervention will start after all baseline testing is complete | Other | Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo |
| Blood DrawBlood samples will be collected biweekly. | Biological | Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo |
| Ketone/Glucose MonitoringHand-held glucometer will be used daily to monitor dietary intervention adherence. | Biological | Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo |
| Body CompositionDEXA Scanning will be done pre-, mid-, and post- intervention. | Other | Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo |
| Urine Analysis24 hour urine collection will be done biweekly. | Biological | Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo |
| Neuropsychological Measures - ANAMThe 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. | Behavioural | Ketogenic Diet, Ketogenic Diet + Ketone Salt, Low Fat Diet +Placebo |
Primary outcome
Daily Ketone/Glucose Monitoring
Time frame: Up to 6 weeks
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.
Cholesterol (mg/dl)
Time frame: up to six weeks
Fasting venous blood will be collected biweekly to measure cholesterol.
Insulin (mIU/L)
Time frame: up to six weeks
Fasting venous blood will be collected biweekly.
Glucose (mg/dL)
Time frame: up to six weeks
Fasting venous blood will be collected biweekly.
Lean Mass (kg)
Time frame: up to six weeks
DEXA Scanning will be biweekly to assess lean mass
Fat Mass (kg)
Time frame: up to six weeks
DEXA Scanning will be biweekly to assess fat mass
4 secondary outcomes
Neuropsychological Outcome 1 - Reaction time (Throughput)
Time frame: up to six weeks
Neuropsychological Outcome 1 - Visual Short Term Memory (Throughput)
Time frame: up to six weeks
Neuropsychological Outcome 1 - Spatial Processing (Throughput)
Time frame: up to six weeks
Urine Chemistries
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Results publication: PubMed 36248655Kackley 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.
- Results publication: PubMed 36629058Belany 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.
- Results publication: PubMed 36963874Buga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Volek, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Blood Draw and Ketone/Glucose Monitoring in people with Ketogenic Diet and Weight Loss, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Ketone/Glucose Monitoring (time frame: Up to 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449287, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.