Muscle WastingNCT04744142
Effects of Ketones on Muscle Wasting During Caloric Restriction in Lean Females
A study testing Ketone supplementation and Increased protein intake in people with Muscle Wasting and Protein Intake, run by KU Leuven at 1 site in Belgium.
Trial summary
Because of these anabolic properties of ketone bodies and the fact that ketone bodies prevent muscle protein breakdown for gluconeogenesis during energetic stress, ketone bodies can be a promising strategy to prevent or treat skeletal muscle wasting. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Wasting, Protein Intake, Ketosis
- What is being tested?
- Ketone supplementation and Increased protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 1 Jun 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females between 18 and 40 years old
- Fat percentage between 16 and 25%
- Regularly involved in physical activity ( > 6 h/week)
- Use of hormonal contraceptives
- Good health status confirmed by a medical screening
- Stable body weight during the last 3 months prior to the study, i.e. no changes > 2 kg
Who cannot join
- Smoking
- Obsessive pursuit for thinness, evaluated by the Eating Disorder Inventory 3 (EDI-3) 'Pursuit of leanness' (i.e a score higher than 26/32) (see Appendix 5)
- Intake of any medication or nutritional supplement that is proven to affect exercise performance, except oral contraceptives
- Blood donation during the study
- Current participation in another research trial
- Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Because of these anabolic properties of ketone bodies and the fact that ketone bodies prevent muscle protein breakdown for gluconeogenesis during energetic stress, ketone bodies can be a promising strategy to prevent or treat skeletal muscle wasting. Therefore, our aim is to investigate the effect of 3HHB intake on muscle wasting and its adverse consequences during a period of caloric restriction in lean females. In addition, we compare the effects of 3HHB intake with a high protein diet, which is currently considered as the best strategy to minimize lean loss during hypo-energetic periods. To end, we aim to investigate the synergistic effects of the intake of 3HHB in combination with a high protein diet.
Read the detailed description
Thermodynamics state that body mass declines during periods in which energy expenditure exceeds energy intake. This negative energy balance can be obtained either by reducing energy intake, called caloric restriction, by increasing energy expenditure, i.e higher level of physical activity, or the combination of both. The sustained energy deficit results in a net loss of body weight due to losses of both fat and skeletal muscle mass in a ratio of approximately 3:11, depending on the severity of caloric restriction, diet composition and initial body fat percentage. Decreases in muscle mass are due to a combination of downregulated muscle protein synthesis in conjunction with an increased ubiquitin-proteasome-mediated muscle proteolysis, resulting in a negative net protein turnover.
In the context of sports, many athletes try to lose body weight to achieve different goals, such as improving performance by optimizing power-to-weight ratio, competing in a certain body weight category or for aesthetic reasons. However, the loss of body weight is often accompanied by detrimental loss of skeletal muscle mass, which is associated with a myriad of negative consequences including impaired physical performance and increased susceptibility to injury. Hence, athletes undergoing periods of caloric restriction strive for body weight loss via fat loss, while minimizing loss of lean mass. Recent studies have demonstrated that an increased protein intake, higher than the recommended dietary allowance (0.8g/kg/day), attenuates the loss of muscle mass during caloric restriction. Research has shown that the high protein diet has minor effects on muscle proteolysis compared to normal dietary protein but restores muscle protein synthesis, which is probably the primary mechanism by which lean mass is preserved. Specifically, in young healthy athletes, it is shown that a higher protein intake of 1.6-2.4 g per kg body weight per day reduces the loss of muscle mass during short-term caloric restriction periods.
In female athletes, longer periods of low energy availability (with or without an eating disorder) are often interrelated with menstrual dysfunctions and decreased bone mineral density, a syndrome called the 'female athlete triad'. The triad is particularly common in sports that emphasize aesthetics or leanness and can impose lifelong health consequences. However, interventions that minimize loss of lean mass and prevent hormonal and bone metabolism dysregulations in females during periods of caloric restriction, are still missing.
Ketone bodies, i.e. D-β-hydroxybutyrate (βHB), acetoacetate (AcAc) and acetone are naturally occurring chemical compounds synthesized in the liver from circulating fatty acids under conditions of low blood glucose and insulin levels. In normal physiological conditions, the concentration of serum ketone levels remains low (< 0.1 mM). However, during starvation or applying a ketogenic diet, i.e low carbohydrate content, serum concentrations of βHB and AcAc can increase up to 5-8 mM and 1-2 mM, respectively. In these conditions, ketone bodies serve as an alternative and more efficient energy source for various tissues, including the brain, heart and skeletal muscle, thereby 'sparing' the glucose storages. In normal conditions, the brain can only use glucose as an energy fuel to maintain central nervous system functions. Therefore, sparing glucose storages during periods of energetic stress is extremely important for survival. Besides, this sparing of glucose storages prevents the breakdown of muscle proteins which can be used as precursors for gluconeogenesis, providing glucose for the brain and other tissues. Hence, the availability of ketone bodies reduces the breakdown of muscle proteins for gluconeogenesis and, thus, preserves skeletal muscle mass even when energy availability is limited. Therefore, elevating ketone body levels may be an important strategy to prevent skeletal muscle wasting during periods of energetic stress.
Since recently, serum levels of ketone bodies can be increased by the intake of the ketone body ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (3HHB). This orally absorbable ketone body ester is proven safe and well-tolerated in both animals and humans and can elevate ketone body levels within 30 min to 5-6 mM, similar to levels after approximately one week of fasting. The availability of this ketone body ester allows for controlled studies on the effect of ketone bodies on muscle homeostasis without the negative side-effects of starvation and a ketogenic diet, i.e high serum triglyceride and cholesterol levels. The effects of 3HHB on endurance performance is still debated. However, a recent study from our lab showed that post-exercise ingestion of 3HHB increases markers of protein synthesis, which was further confirmed by in vitro experiments. C2C12 myoblasts showed increased leucine-mediated muscle protein synthesis by incubation of physiological concentrations of ketone bodies. Most recently, we found that dietary supplementation with 3HHB substantially improved survival and maintenance of functional capacity and muscular integrity in a mouse model of cancer cachexia.
Because of these anabolic properties of ketone bodies and the fact that ketone bodies prevent muscle protein breakdown for gluconeogenesis during energetic stress, ketone bodies can be a promising strategy to prevent or treat skeletal muscle wasting. Therefore, our aim is to investigate the effect of 3HHB intake on muscle wasting and its adverse consequences during a period of caloric restriction in lean females. In addition, we compare the effects of 3HHB intake with a high protein diet, which is currently considered as the best strategy to minimize lean loss during hypo-energetic periods. To end, we aim to investigate the synergistic effects of the intake of 3HHB in combination with a high protein diet.
- Conditions
- Muscle Wasting, Protein Intake, Ketosis, Caloric Restriction
- Being tested
- Ketone supplementation, Increased protein intake
- Keywords
- resting metabolic rate, β-hydroxybutyrate, caloric restriction, muscle mass, ketone ester
- Medical subject headings
- Muscular Atrophy, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone supplementationDrug
Also called Placebo vs ketone supplementation
Subjects receive either placebo or ketone ester supplementation
Increased protein intakeDietary supplement
Also called Normal vs increased protein intake
Subjects receive either normal or increased protein intake
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Received 10% protein in nutrition + placebo supplement |
| Ketone | Experimental | Received 10% protein in nutrition + 3x20g B-hydroxybutyrate per day Receives: Drug: Ketone supplementation |
| High protein | Experimental | Received 30% protein in nutrition + placebo supplement Receives: Dietary Supplement: Increased protein intake |
| High protein + ketone | Experimental | Received 30% protein in nutrition + 3x20g B-hydroxybutyrate per day Receives: Drug: Ketone supplementation; Dietary Supplement: Increased protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
The amount of muscle mass loss
Measured: Muscle mass is measured before and after 4 weeks of caloric restriction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Jan 2018
- Primary completion20 Dec 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WastingStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were pair-matched for body weight, % body fat and energy intake, where after they were randomly allocated to an experimental group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hespel, KU Leuven
- Investigators
- Katrien Koppo, PhD, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744142
- Sponsor's protocol ID
- S61133
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in internationally peer-reviewed journals
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketones on Muscle Wasting During Caloric Restriction in Lean Females
- ClinicalTrials.gov ID
- NCT04744142
- Acronym / sponsor ID
- S61133
- Conditions
- Muscle Wasting, Protein Intake, Ketosis, Caloric Restriction
- Keywords
- resting metabolic rate, β-hydroxybutyrate, caloric restriction, muscle mass, ketone ester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 8 Feb 2021 (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.
Because of these anabolic properties of ketone bodies and the fact that ketone bodies prevent muscle protein breakdown for gluconeogenesis during energetic stress, ketone bodies can be a promising strategy to prevent or treat skeletal muscle wasting. Therefore, our aim is to investigate the effect of 3HHB intake on muscle wasting and its adverse consequences during a period of caloric restriction in lean females. In addition, we compare the effects of 3HHB intake with a high protein diet, which is currently considered as the best strategy to minimize lean loss during hypo-energetic periods. To end, we aim to investigate the synergistic effects of the intake of 3HHB in combination with a high protein diet.
Detailed description
Thermodynamics state that body mass declines during periods in which energy expenditure exceeds energy intake. This negative energy balance can be obtained either by reducing energy intake, called caloric restriction, by increasing energy expenditure, i.e higher level of physical activity, or the combination of both. The sustained energy deficit results in a net loss of body weight due to losses of both fat and skeletal muscle mass in a ratio of approximately 3:11, depending on the severity of caloric restriction, diet composition and initial body fat percentage. Decreases in muscle mass are due to a combination of downregulated muscle protein synthesis in conjunction with an increased ubiquitin-proteasome-mediated muscle proteolysis, resulting in a negative net protein turnover.
In the context of sports, many athletes try to lose body weight to achieve different goals, such as improving performance by optimizing power-to-weight ratio, competing in a certain body weight category or for aesthetic reasons. However, the loss of body weight is often accompanied by detrimental loss of skeletal muscle mass, which is associated with a myriad of negative consequences including impaired physical performance and increased susceptibility to injury. Hence, athletes undergoing periods of caloric restriction strive for body weight loss via fat loss, while minimizing loss of lean mass. Recent studies have demonstrated that an increased protein intake, higher than the recommended dietary allowance (0.8g/kg/day), attenuates the loss of muscle mass during caloric restriction. Research has shown that the high protein diet has minor effects on muscle proteolysis compared to normal dietary protein but restores muscle protein synthesis, which is probably the primary mechanism by which lean mass is preserved. Specifically, in young healthy athletes, it is shown that a higher protein intake of 1.6-2.4 g per kg body weight per day reduces the loss of muscle mass during short-term caloric restriction periods.
In female athletes, longer periods of low energy availability (with or without an eating disorder) are often interrelated with menstrual dysfunctions and decreased bone mineral density, a syndrome called the 'female athlete triad'. The triad is particularly common in sports that emphasize aesthetics or leanness and can impose lifelong health consequences. However, interventions that minimize loss of lean mass and prevent hormonal and bone metabolism dysregulations in females during periods of caloric restriction, are still missing.
Ketone bodies, i.e. D-β-hydroxybutyrate (βHB), acetoacetate (AcAc) and acetone are naturally occurring chemical compounds synthesized in the liver from circulating fatty acids under conditions of low blood glucose and insulin levels. In normal physiological conditions, the concentration of serum ketone levels remains low (< 0.1 mM). However, during starvation or applying a ketogenic diet, i.e low carbohydrate content, serum concentrations of βHB and AcAc can increase up to 5-8 mM and 1-2 mM, respectively. In these conditions, ketone bodies serve as an alternative and more efficient energy source for various tissues, including the brain, heart and skeletal muscle, thereby 'sparing' the glucose storages. In normal conditions, the brain can only use glucose as an energy fuel to maintain central nervous system functions. Therefore, sparing glucose storages during periods of energetic stress is extremely important for survival. Besides, this sparing of glucose storages prevents the breakdown of muscle proteins which can be used as precursors for gluconeogenesis, providing glucose for the brain and other tissues. Hence, the availability of ketone bodies reduces the breakdown of muscle proteins for gluconeogenesis and, thus, preserves skeletal muscle mass even when energy availability is limited. Therefore, elevating ketone body levels may be an important strategy to prevent skeletal muscle wasting during periods of energetic stress.
Since recently, serum levels of ketone bodies can be increased by the intake of the ketone body ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (3HHB). This orally absorbable ketone body ester is proven safe and well-tolerated in both animals and humans and can elevate ketone body levels within 30 min to 5-6 mM, similar to levels after approximately one week of fasting. The availability of this ketone body ester allows for controlled studies on the effect of ketone bodies on muscle homeostasis without the negative side-effects of starvation and a ketogenic diet, i.e high serum triglyceride and cholesterol levels. The effects of 3HHB on endurance performance is still debated. However, a recent study from our lab showed that post-exercise ingestion of 3HHB increases markers of protein synthesis, which was further confirmed by in vitro experiments. C2C12 myoblasts showed increased leucine-mediated muscle protein synthesis by incubation of physiological concentrations of ketone bodies. Most recently, we found that dietary supplementation with 3HHB substantially improved survival and maintenance of functional capacity and muscular integrity in a mouse model of cancer cachexia.
Because of these anabolic properties of ketone bodies and the fact that ketone bodies prevent muscle protein breakdown for gluconeogenesis during energetic stress, ketone bodies can be a promising strategy to prevent or treat skeletal muscle wasting. Therefore, our aim is to investigate the effect of 3HHB intake on muscle wasting and its adverse consequences during a period of caloric restriction in lean females. In addition, we compare the effects of 3HHB intake with a high protein diet, which is currently considered as the best strategy to minimize lean loss during hypo-energetic periods. To end, we aim to investigate the synergistic effects of the intake of 3HHB in combination with a high protein diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects were pair-matched for body weight, % body fat and energy intake, where after they were randomly allocated to an experimental group
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Received 10% protein in nutrition + placebo supplement |
| Ketone | Experimental | Drug: Ketone supplementationReceived 10% protein in nutrition + 3x20g B-hydroxybutyrate per day |
| High protein | Experimental | Dietary Supplement: Increased protein intakeReceived 30% protein in nutrition + placebo supplement |
| High protein + ketone | Experimental | Drug: Ketone supplementation, Dietary Supplement: Increased protein intakeReceived 30% protein in nutrition + 3x20g B-hydroxybutyrate per day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females between 18 and 40 years old
- Fat percentage between 16 and 25%
- Regularly involved in physical activity ( > 6 h/week)
- Use of hormonal contraceptives
- Good health status confirmed by a medical screening
Key exclusion criteria (6 listed)
- Smoking
- Obsessive pursuit for thinness, evaluated by the Eating Disorder Inventory 3 (EDI-3) 'Pursuit of leanness' (i.e a score higher than 26/32) (see Appendix 5)
- Intake of any medication or nutritional supplement that is proven to affect exercise performance, except oral contraceptives
- Blood donation during the study
- Current participation in another research trial
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 |
|---|---|---|
| Ketone supplementationAlso: Placebo vs ketone supplementationSubjects receive either placebo or ketone ester supplementation | Drug | High protein + ketone, Ketone |
| Increased protein intakeAlso: Normal vs increased protein intakeSubjects receive either normal or increased protein intake | Dietary supplement | High protein, High protein + ketone |
Primary outcome
Muscle mass
Time frame: Muscle mass is measured before and after 4 weeks of caloric restriction
The amount of muscle mass loss
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 8 Feb 2021.
- Individual participant dataSharing planned: No. Results will be published in internationally peer-reviewed journals
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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.
Katrien Koppo, PhD study director
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone supplementation and Increased protein intake in people with Muscle Wasting and Protein Intake, run by KU Leuven at 1 site in Belgium.
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 6 inclusion and 6 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 8 Feb 2021. 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 Belgium. 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?
Muscle mass (time frame: Muscle mass is measured before and after 4 weeks of caloric restriction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.