Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects
► d-β-hydroxybutyrate-(R)-1,3-butanediol was given as a drink to healthy adults. ► Blood ketones were elevated, but the ketone monoester was not detected. ► The ketone monoester was well tolerated. ► Ingestion of the ketone monoester is a safe and viable way to elevate blood ketone concentrations. I...
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| Published in | Regulatory toxicology and pharmacology Vol. 63; no. 3; pp. 401 - 408 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier Inc
01.08.2012
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| Subjects | |
| Online Access | Get full text |
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| Abstract | ► d-β-hydroxybutyrate-(R)-1,3-butanediol was given as a drink to healthy adults. ► Blood ketones were elevated, but the ketone monoester was not detected. ► The ketone monoester was well tolerated. ► Ingestion of the ketone monoester is a safe and viable way to elevate blood ketone concentrations.
Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1–2h, reaching 3.30mM and 1.19mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8–3.1h for β-hydroxybutyrate and 8–14h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714mg/kg body weight, three times daily, over 5days (equivalent to 0.42, 1.07, and 2.14g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. |
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| AbstractList | Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of beta -hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30mM and 1.19mM for beta -hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for beta -hydroxybutyrate and 8-14h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714mg/kg body weight, three times daily, over 5days (equivalent to 0.42, 1.07, and 2.14g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1–2h, reaching 3.30mM and 1.19mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8–3.1h for β-hydroxybutyrate and 8–14h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714mg/kg body weight, three times daily, over 5days (equivalent to 0.42, 1.07, and 2.14g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of ( R )-3-hydroxybutyl ( R )-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1–2 h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8–3.1 h for β-hydroxybutyrate and 8–14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of ( R )-3-hydroxybutyl ( R )-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. ► d-β-hydroxybutyrate-(R)-1,3-butanediol was given as a drink to healthy adults. ► Blood ketones were elevated, but the ketone monoester was not detected. ► The ketone monoester was well tolerated. ► Ingestion of the ketone monoester is a safe and viable way to elevate blood ketone concentrations. Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1–2h, reaching 3.30mM and 1.19mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8–3.1h for β-hydroxybutyrate and 8–14h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714mg/kg body weight, three times daily, over 5days (equivalent to 0.42, 1.07, and 2.14g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for β-hydroxybutyrate and 8-14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for β-hydroxybutyrate and 8-14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet.Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for β-hydroxybutyrate and 8-14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet. |
| Author | VanItallie, Theodore B. Veech, Richard L. Musa-Veloso, Kathy Ho, Manki Todd King, M. Tchabanenko, Kirill Pawlosky, Robert Roberts, Ashley Clarke, Kieran Carter, Emma Robertson, Jeremy |
| AuthorAffiliation | a Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK c Laboratory of Metabolic Control, NIAAA/NIH, Rockville, MD, USA d Intertek Cantox, Mississauga, Canada e Department of Medicine, St. Luke’s–Roosevelt Hospital Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA b Department of Chemistry, University of Oxford, Oxford, UK |
| AuthorAffiliation_xml | – name: c Laboratory of Metabolic Control, NIAAA/NIH, Rockville, MD, USA – name: a Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK – name: b Department of Chemistry, University of Oxford, Oxford, UK – name: d Intertek Cantox, Mississauga, Canada – name: e Department of Medicine, St. Luke’s–Roosevelt Hospital Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA |
| Author_xml | – sequence: 1 givenname: Kieran surname: Clarke fullname: Clarke, Kieran email: kieran.clarke@dpag.ox.ac.uk organization: Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK – sequence: 2 givenname: Kirill surname: Tchabanenko fullname: Tchabanenko, Kirill organization: Department of Chemistry, University of Oxford, Oxford, UK – sequence: 3 givenname: Robert surname: Pawlosky fullname: Pawlosky, Robert organization: Laboratory of Metabolic Control, NIAAA/NIH, Rockville, MD, USA – sequence: 4 givenname: Emma surname: Carter fullname: Carter, Emma organization: Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK – sequence: 5 givenname: M. surname: Todd King fullname: Todd King, M. organization: Laboratory of Metabolic Control, NIAAA/NIH, Rockville, MD, USA – sequence: 6 givenname: Kathy surname: Musa-Veloso fullname: Musa-Veloso, Kathy organization: Intertek Cantox, Mississauga, Canada – sequence: 7 givenname: Manki surname: Ho fullname: Ho, Manki organization: Intertek Cantox, Mississauga, Canada – sequence: 8 givenname: Ashley surname: Roberts fullname: Roberts, Ashley organization: Intertek Cantox, Mississauga, Canada – sequence: 9 givenname: Jeremy surname: Robertson fullname: Robertson, Jeremy organization: Department of Chemistry, University of Oxford, Oxford, UK – sequence: 10 givenname: Theodore B. surname: VanItallie fullname: VanItallie, Theodore B. organization: Department of Medicine, St. Luke’s–Roosevelt Hospital Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA – sequence: 11 givenname: Richard L. surname: Veech fullname: Veech, Richard L. organization: Laboratory of Metabolic Control, NIAAA/NIH, Rockville, MD, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22561291$$D View this record in MEDLINE/PubMed |
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| Keywords | Ketone monoester Cl/F Cmax GC–MS T1/2 ECG Tolerability Ketone AUC (R)-3-hydroxybutyl (R)-3-hydroxybutyrate β-Hydroxybutyrate bw Tmax Kinetics Safety TMS Acetoacetate BMI |
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| Snippet | ► d-β-hydroxybutyrate-(R)-1,3-butanediol was given as a drink to healthy adults. ► Blood ketones were elevated, but the ketone monoester was not detected. ►... Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and... |
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| SubjectTerms | (R)-3-hydroxybutyl (R)-3-hydroxybutyrate 3-hydroxybutyric acid Acetoacetate Adolescent Adult adults blood body weight cognition Dietary Supplements Female gastrointestinal system half life Humans Hydroxybutyrates - administration & dosage Hydroxybutyrates - adverse effects Hydroxybutyrates - pharmacokinetics hyperketonemia ingestion ketogenic diet Ketone ketones Ketones - blood Kinetics Male Middle Aged milk Safety Tolerability volunteers Young Adult β-Hydroxybutyrate |
| Title | Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects |
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